EMC Documentum Quality and Manufacturing

Transcription

1 EMC Documentum Quality and Manufacturing Version 4.0 User Guide EMC Corporation Corporate Headquarters Hopkinton, MA

2 Legal Notice Copyright EMC Corporation. All Rights Reserved. EMC believes the information in this publication is accurate as of its publication date. The information is subject to change without notice. THE INFORMATION IN THIS PUBLICATION IS PROVIDED AS IS. EMC CORPORATION MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WITH RESPECT TO THE INFORMATION IN THIS PUBLICATION, AND SPECIFICALLY DISCLAIMS IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Use, copying, and distribution of any EMC software described in this publication requires an applicable software license. For the most up-to-date listing of EMC product names, see EMC Corporation Trademarks on EMC.com. Adobe and Adobe PDF Library are trademarks or registered trademarks of Adobe Systems Inc. in the U.S. and other countries. All other trademarks used herein are the property of their respective owners. Documentation Feedback Your opinion matters. We want to hear from you regarding our product documentation. If you have feedback about how we can make our documentation better or easier to use, please send us your feedback directly at ECD.Documentation.Feedback@emc.com

3 Table of Contents Preface... 5 Chapter 1 Overview... 7 Quality and Manufacturing... 8 Quality and Manufacturing Document Management... 9 Chapter 2 Roles Site-Based User Roles Authors Reviewers Approvers Coordinators Readers Auditors Administrators Chapter 3 Create Documents Controlled Documents Creating a Controlled Document Creating a Copy of a Controlled Document (Technology Transfer) Creating a Relationship between Two Documents File Naming and Versioning Importing a File from your Computer Document Updates Editing a Document Checking in a Document Configuring Content Templates Creating a Content Template Modifying a Content Template Configuring Dictionaries and Taxonomies Chapter 4 Request and Track Document Changes Change Requests Creating a Change Request Attaching Documents to a Change Request Closing a Change Request Chapter 5 Working with Documents Locating Documents Finding Documents using a Public Search Finding Documents using Facets

4 Table of Contents Viewing Documents and their Properties Viewing the Document History Deleting and Restoring a Document Exporting the Doc List to Microsoft Excel Find Documents Additional Menu Functions Chapter 6 Review and Approve Documents Workflow Process Processing a Change Request Document Review and Approval Adding a Document to a Workflow Self-approving a Document Performing Tasks in a Workflow Viewing the Audit Trail Categorizing Inbox Tasks Processing Documents in a Workflow Collaborative Editing Editing a Document in a Workflow Consolidating Document Changes Reviewing Documents in a Review Task Reviewing Document Feedback from Reviewers Approving Documents Reviewing Document Feedback from Approvers Acknowledging Change Requests Releasing Control Category 1 Documents as Effective Versions Working with Effective or Approved Documents Suspending a Document Withdrawing a Document Superseded Documents Setting the Planned Effective Date for a Document Updating the Periodic Review Date for a Document Viewing Document Status Viewing Workflow Progress Workflow Task Performer Changes Updating Workflow Task Performers Stopping a Workflow Delegating a Task as a Workflow Supervisor Delegating a Task as a User Reassigning Roles Chapter 7 Print and Export Documents Printing a Control Category 1 Document Exporting Control Category 1 Documents

5 Preface This guide describes the default behavior of EMC Documentum Quality and Manufacturing (Documentum Q&M), part of the EMC Documentum for Life Sciences solution suite. The solution is built on the Documentum D2 web application and Documentum platform. Documentum D2 is a web-based application that enables users to store, retrieve, and manage documents in a Documentum repository. It is highly customizable through a configuration application that does not require programming knowledge. Documentum D2 consists of the following components: Documentum D2 Configuration (D2-Config): The configuration application that enables you to configure settings for security, workflows, document classification, and the client user interface. Documentum D2 Client (D2 Client): The main application that is used to interact with documents in the repository. Additional Documentum D2 components that are used in Documentum Q&M are: Documentum D2 Office Integration (O2): Microsoft Office and Outlook properties synchronization for documents and . Documentum D2 PDF Integration (C2): PDF file control for watermarking and controlled printing. Intended Audience This guide is intended for those who use the EMC Documentum Quality and Manufacturing solution, part of the EMC Documentum for Life Sciences solution suite. Revision History Revision Date October 2016 Description Updated the note in Creating a Copy of a Controlled Document (Technology Transfer), page 19. Updated the content for Launch Period Review WF in Workflow Process, page 39. 5

6 Preface Revision Date September 2016 June 2016 Description Removed all references to expiration date and expiry review from Releasing Control Category 1 Documents as Effective Versions, page 57. Updated the content related to periodic review in the section, Releasing Control Category 1 Documents as Effective Versions, page 57. Added a note about annotations not supported in Microsoft Excel or Microsoft PowerPoint native formats in Editing a Document in a Workflow, page 52. Added a note in the section, Updating Workflow Task Performers, page 64. Updated the section Withdrawing a Document, page 59. April 2016 June 2015 Added a note about the Track Changes feature in Microsoft Word 2013 in Editing a Document in a Workflow, page 52. Added a note in the Releasing Control Category 1 Documents as Effective Versions, page 57 section. Initial publication. 6

7 Overview Chapter 1 The EMC Documentum Quality and Manufacturing (Documentum Q&M) solution, part of the EMC Documentum for Life Sciences solution suite, enables Life Sciences organizations to control quality and manufacturing documents, automate workflows across the extended enterprise, and ensure compliance with GMP (Good Manufacturing Practices) standards. Documentum Q&M provides governance, tools, document control functionality, and embedded life sciences industry models. This solution includes: Predefined industry-standard data models, dictionaries, and taxonomies Enables Title 21 CFR PART 11 compliance including electronic signature capabilities Automated policy enforcement and audit trails Automated document routing Document overlays and watermarks tailored to business needs Flexible lifecycles and workflows with four levels of control to streamline approval Change request form and process to support document change control practices Simplified document handling based on metadata and policy inheritance Product and project library management for business owners to reduce IT dependencies Enforced signatures in review and approval tasks ensures compliant policies and simplifies the document approval process Enforced business rules, such as rules for review and approval, periodic review, and training workflows View, export, and print control for managing controlled documents This section contains the following topics: Quality and Manufacturing, page 8 Quality and Manufacturing Document Management, page 9 7

8 Overview Quality and Manufacturing Life Sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost while adhering to high quality standards. To achieve and maintain compliance with health authority regulations, pharmaceutical manufacturers must follow GMP standards of which document control is an essential component. Quality and Manufacturing areas create numerous documents to plan and record their activities, actions, and results. Documentum Q&M documents includes a comprehensive inventory of documents that belong to the following categories: Governance and Procedure Manufacturing Quality Facility and Organization Packaging and Labeling Validation Reference and Training Change Requests The following figure shows the domains included in the EMC Documentum for Life Sciences solution suite: 8

9 Overview Related topic: Quality and Manufacturing Document Management, page 9 Quality and Manufacturing Document Management Documentum Q&M addresses the challenges of managing documents governing manufacturing, quality, compliance, and other standard operating procedures. It enables you to manage controlled documents efficiently to meet strict regulatory requirements. After finalizing the documentation, you can automatically distribute it to employees and partners both internally and externally. Documentum Q&M automatically replaces previous versions with the latest approved documents, ensuring that the most current version is in use across the organization. The following figure illustrates the Documentum Q&M Process: Users request new documents or changes to a document. After change request approval, authors can create and update documents and then send them for review and approval. Authors can send documents to a group of reviewers for initial feedback and collaborative editing. These reviewers co-author the document and they can make changes to the document at the same time. Authors can then incorporate the changes into the document and make additional revisions. Once the initial authoring is complete, Authors can send the document for formal review and approval. When complete, quality and manufacturing documents have a status of Effective or Approved and policy and procedure documents have a status of Effective or Approved. Once the document is final and made effective, a specified group of readers can read the document. The document type determines the number of users involved in the review and approval process. For example, procedure documents require the highest level of review and approval. They require formal review along with signoff by the Quality Organization (QO). In addition to a Reviewer and Approver, this process requires a QO Approver and a Document Coordinator. The Document Coordinator manages the release of the documents by making them effective (Effective or Approved). The following figure illustrates an example of the highest-level review and approval process: 9

10 Overview Users refer to the highest-level review and approval process as a four-eyes approval because at least four sets of eyes are on the document. Documentum Q&M automatically controls the movement of the document from user to user by placing tasks in the inbox of the users. For example, a Reviewer receives a task to review a document and an approver receives a task to approve a document. This solution provides additional security to control who can view the documents and when they can view the documents. For example, Readers and Auditors have read-only access to specified documents and they cannot view documents that are in progress and not approved. Documentum Q&M monitors activities in the system and provides real-time information on the status of the documents. For example, Authors and Document Coordinators can view the status of a document and monitor the progress of document tasks. Auditors can view the document history of Effective or Approved and Withdrawn documents to assist them with their audits. 10

11 Roles Chapter 2 A role is a type of group that contains users or other groups that are assigned a specific role. Roles provide a means of defining groups that have a particular function within a system. For example, pharmaceutical companies manage their huge set of documentation the assignment of roles such as Authors, Reviewers, Approvers, Managers, and so on. Each role can have one or more people designated to perform the activity. This section contains the following topics: Site-Based User Roles, page 11 Authors, page 12 Reviewers, page 12 Approvers, page 13 Coordinators, page 13 Readers, page 14 Auditors, page 15 Administrators, page 15 Site-Based User Roles In Documentum Q&M, document security is defined by the site that is applicable to the document. A document can belong to one or more sites that the organization has. Therefore, access to a document by a user also depends on the site that the user belong to and so, user roles are defined based on site instead of document categories, such as boston_authors, boston_reviewers, princeton_reviewers, princeton_readers, vancouver_approvers, and so on. For example, if a document was created for the Boston site, all Boston users groups such as boston_authors, boston_readers, boston_reviewers, and so on, will have access to that document. Users from Princeton, for instance, will not be able to access the document. Note: To support site-based roles, a separate dictionary, GMP_applicable_sites, is provided in D2 Config. This dictionary lists the applicable sites and the user roles and groups for the corresponding sites. To add a site-based user group, you must manually add it to the dictionary. The EMC Documentum for Life Sciences Administration Guide provides more information about adding site-based user roles. 11

12 Roles Authors Authors create documents and submit them for collaborative editing, review, and approval. They can self-approve documents that do not require formal review and approval. Authors can also create change requests and send change requests on review and approval workflows. Authors can monitor the progress of document workflow tasks. They can change workflow task performers and stop the workflows. The following table lists Author tasks and provides links to the instructions: Task Instructions Create controlled documents Creating a Controlled Document, page 17 Import controlled documents Importing a File from your Computer, page 21 Send a document for collaborative editing Adding a Document to a Workflow, page 47 Send a document for review and approval Adding a Document to a Workflow, page 47 Self-approve documents Self-approving a Document, page 47 Edit a document in a collaborative editing workflow Consolidate document changes from each reviewer Review document feedback from reviewers Editing a Document in a Workflow, page 52 Consolidating Document Changes, page 52 Reviewing Document Feedback from Reviewers, page 54 Create change requests Creating a Change Request, page 31 Work with Effective or Approved documents Working with Effective or Approved Documents, page 59 View the document history Viewing the Audit Trail, page 50 View document status Viewing Document Status, page 61 Delete and restore a document Deleting and Restoring a Document, page 35 View workflow progress Viewing Workflow Progress, page 62 Change workflow task performers Workflow Task Performer Changes, page 62 Find documents using Public searches Find Documents, page 36 Reviewers Reviewers review documents using annotations and edit documents. They are responsible for technical review during the authoring and review cycle. Reviewers complete workflow tasks and can browse and search for documents. The following table lists Reviewer tasks and provides links to the instructions: 12

13 Roles Task Instructions Performing workflow tasks Performing Tasks in a Workflow, page 48 Participate in the collaborative editing of documents Editing a Document in a Workflow, page 52 Review and annotate documents Reviewing Documents in a Review Task, page 53 View document status Viewing Document Status, page 61 Delegate a task to another user Delegating a Task as a User, page 65 Approvers Approvers are responsible for approving controlled documents. Some documents require electronic signatures. Documents that require formal review and approval may also need signoff by Quality Organization Approvers. Approvers complete workflow tasks and can browse and search for documents. The following table lists Approver tasks and provides links to the instructions: Task Instructions Performing workflow tasks Performing Tasks in a Workflow, page 48 Approving documents Approving Documents, page 55 View document status Viewing Document Status, page 61 Delegate a task to another user Delegating a Task as a User, page 65 Coordinators Document Coordinators manage the release of controlled documents. They can also create documents and submit them for collaborative editing, review, and approval. Document Coordinators monitor the progress of document workflow tasks. They can change workflow task performers and stop the workflows. Document Coordinators can also send documents on a TBR workflow and manage the periodic review workflow. When the periodic review workflow is launched, the Coordinator receives the first task and then assigns the periodic reviewers. Document Coordinators also manage all change request in a particular domain. They can change Authors, Reviewers, and Approvers for the documents affected by change requests. The following table lists Coordinator tasks and provides links to the instructions: Task Instructions Create change requests Creating a Change Request, page 31 13

14 Roles Task Manage the release of documents Instructions Releasing Control Category 1 Documents as Effective Versions, page 57 Working with Effective or Approved Documents, page 59 View the document history Viewing the Audit Trail, page 50 Delete and restore a document Deleting and Restoring a Document, page 35 View document status Viewing Document Status, page 61 View workflow progress Viewing Workflow Progress, page 62 Change workflow task performers Workflow Task Performer Changes, page 62 Find documents using Public searches Find Documents, page 36 Create controlled documents Creating a Controlled Document, page 17 Import controlled documents Importing a File from your Computer, page 21 Send a document for collaborative editing Adding a Document to a Workflow, page 47 Send a document for review and approval Adding a Document to a Workflow, page 47 Self-approve documents Self-approving a Document, page 47 Edit a document in a collaborative editing workflow Consolidate document changes from each reviewer Review document feedback from reviewers Release Cat 1 documents as Effective, send to a TBR workflow, and set the periodic review date Update the periodic review date Perform controlled printing of documents Update dictionaries and taxonomies Editing a Document in a Workflow, page 52 Consolidating Document Changes, page 52 Reviewing Document Feedback from Reviewers, page 54 Releasing Control Category 1 Documents as Effective Versions, page 57 Updating the Periodic Review Date for a Document, page 61 Printing a Control Category 1 Document, page 67 Configuring Dictionaries and Taxonomies, page 24 Readers Readers have read-only access to Effective or Approved versions of documents. They browse for, search, and read documents. Readers also receive notification that they must read a document through a To Be Read (TBR) task in their inbox. When they finish reading the document, they formally sign off that they read it. This process can ensure that the recipients understand a process or procedure before the document becomes effective. 14

15 Roles The following table lists reader and recipient tasks and provides links to the instructions: Task Instructions Performing workflow tasks Performing Tasks in a Workflow, page 48 Browse and search for documents. Locating Documents, page 33 Finding Documents using a Public Search, page 33 Auditors Auditors have read-only access to audit logs as well as Effective or Approved, Superseded, and Withdrawn documents. They can view document content, history, and properties. The following table lists Auditor tasks and provides links to the instructions: Task Instructions Browse and search for documents. Locating Documents, page 33 Finding Documents using a Public Search, page 33 View the document history Viewing the Document History, page 34 View document properties Export content to Microsoft Excel Viewing Documents and their Properties, page 34 Exporting the Doc List to Microsoft Excel, page 35 Administrators Administrators can access administrative functions, but they do not have access to controlled documents. The following Administrator tasks are available in the Administration view (known as the Administration widget): Administer group membership Administer dictionaries Administer taxonomies 15

16 Roles The EMC Documentum D2 User Guide provides more information. Configuring Dictionaries and Taxonomies, page 24 provides the steps for configuring taxonomies and dictionaries in Documentum Q&M. 16

17 Create Documents Chapter 3 This section is for Authors who create documents. This section contains the following topics: Controlled Documents, page 17 File Naming and Versioning, page 21 Importing a File from your Computer, page 21 Document Updates, page 21 Configuring Content Templates, page 22 Configuring Dictionaries and Taxonomies, page 24 Controlled Documents Documentum Q&M uses dictionaries and taxonomies to store products, product codes, product manufacturers, material, equipment, and packaging and label information. The documents that you create inherit values from the taxonomies and dictionaries and automatically populate the Properties of the document. Documents can also inherit data from similar documents. This section contains the following topics: Creating a Controlled Document, page 17 Creating a Copy of a Controlled Document (Technology Transfer), page 19 Creating a Relationship between Two Documents, page 20 Creating a Controlled Document 1. Log in as a member of the Author group. 2. From the repository, select a similar document if you want the document to inherit data from an existing document. 3. Select New > Content from the menu bar. 4. In the Creation profile field, select a document category. 17

18 Create Documents 5. In the Group field, select a GMP group. 6. In the Subgroup field, select a GMP subgroup and then click Next. The Property page appears, which is defined as per the document category. The tabs on the page are configured for each document category. The Classification, Traceability, Document Info, and Process Info tabs are common for all documents in the system. In addition to these tabs, you might view additional tabs depending on the document category for which you are creating the document. 7. On the Classification tab of the Edit Properties page, select or type information in the required fields. The Responsibility field lists all the groups and users applicable to the site. You can select a particular user or a group of users who will be responsible for the document. The Artifact Name field is automatically filled with the Subgroup information if there is no artifact name under the subgroup in the document inventory. For Cat 1 documents, the Training Required radio button is set to Yes by default. For Cat 2 and 3 documents, it is set to No. If you select another language in the Language field, you can provide the English Title in the optional field that appears. 8. On the Traceability tab, select or type information in the fields. The Previous Document Number field is used to link documents that are transferred from the Documentum R&D solution to the Q&M solution. The Notification List lists the user groups that are notified whenever the document goes through a lifecycle state change. 9. On the Document Info tab, view the document properties labels. When creating a new document, this tab appears blank. 10. On the Process Info tab, select or type the required information. This tab displays the control category of the document, the review interval, review notification days, and review notification recipients. The fields that appear vary according to control category. Only Document Coordinators can edit these fields for Cat 1 and 2 documents. Authors can edit these fields for Cat 3 documents. 11. Click Next. 12. The document appears in its native format. From the content s native application, edit the content of the document as needed. To view the content, refresh the screen. For example, if the native format is Microsoft Word, press Ctrl-A and then F9 to update the content. The EMC Documentum D2 Administration Guide provides information on configuring Microsoft Office products to show D2 properties. When you finish, save and close the document. 13. Click Check In and Finish. The system creates the document with a minor version number and file name. The document is checked in. Based on the document type and Control Category, the document is assigned a lifecycle. The system also stores the document in a directory structure based on the document category, site, and the required fields in the Classification tab on the Edit Properties page. 18

19 Create Documents Related topic: File Naming and Versioning, page 21 Creating a Copy of a Controlled Document (Technology Transfer) Documentum R&D enables you to create a copy of the document that is in the Approved state and relate the copy to the original document. This is also known as Technology Transfer. Currently, this feature is only applicable to Quality documents in Documentum R&D. Out-of-the-box, Authors can create a copy of a Quality document into a Manufacturing document, that is, perform a technology transfer of Quality-related information into Manufacturing documents, which are a part of Documentum Q&M. Note: For this feature, you must have both Documentum R&D and Documentum Q&M installed in your environment. To perform the technology transfer, the user must be a member of both the cd_regulatory_managers and cd_quality_doc_authors or cd_quality_doc_coordinators groups. The user must be part of the GMP roles, cd_<applicable site>_coordinators or cd_<applicable site>_authors to create GMP documents. The system does not allow you to create a copy of a selected Quality document through the New > Content menu option, which is disabled. Instead, you must use the Technology Transfer menu option. This option calls up a creation profile that creates a special subset of documents called Manufacturing (Copy from Quality). 1. Log in as a member of the cd_regulatory_managers or cd_quality_authors group. 2. In the Doc List, right-click a Quality document that is in the Draft or Effective state, and click Technology Transfer. 3. On the Fill creation profile page: a. In the Group field, select a Good Manufacturing Practices (GMP) group. b. In the Subgroup field, select a GMP subgroup and then click Next. The Creation profile field is set to Manufacturing (Copy from Quality) and cannot be edited. 4. On the Edit Properties page, select or type information in the fields associated with the following tabs: a. On the Classification tab, select or type information in the required fields. The Responsibility field lists all the groups and users applicable to the site. You can select a particular user or a group of users who will be responsible for the document. The Artifact Name field is automatically filled with the Subgroup information if there is no artifact name under the subgroup in the document inventory. For Category 1 documents, the Training Required radio button is set to Yes by default. For Category 2 and 3 documents, it is set to No. If you select another language in the Language field, you can provide the English Title in the optional field that appears. b. On the Traceability tab, select or type information in the fields. 19

20 Create Documents The Previous Document Number field is used to link documents that are transferred from the Document R&D solution to the Q&M solution. The Notification List lists the user groups that are notified whenever the document goes through a lifecycle state change. 5. On the Document Info tab, view the document properties labels. When creating a new document, this tab appears blank. 6. On the Process Info tab, select or type the required information. This tab displays the control category of the document, the review interval, review notification days, and review notification recipients. The fields that appear vary according to control category. Only Document Coordinators can edit these fields for Category 1 and 2 documents. Authors can edit these fields for Category 3 documents. 7. Click Next. 8. The document appears in its native format. From the content s native application, edit the content of the document as needed. To view the content, refresh the screen. For example, if the native format is Microsoft Word, press Ctrl-A and then F9 to update the content. The EMC Documentum D2 Administration Guide provides information on configuring Microsoft Office products to show D2 properties. When you finish, save and close the document. 9. Click Check In and Finish. The system creates the document with a minor version number and file name. The document is checked in. Based on the document type and Control Category, the document is assigned a lifecycle. The system also stores the document, which is in the Draft state, in the Manufacturing cabinet in Documentum Q&M. The Relations widget lists the source document from which the copy was created with the relation type Transferred From. Whenever a copy of a document is created or when the status of the copy changes, the system sends an notification to the Authors of the original document about the changes. Creating a Relationship between Two Documents 1. Log in as a member of the Author group. 2. In the Doc List widget, select a document. 3. Select Content > Create relation from the menu bar. 4. In the New relation creation dialog box, in the Relation target field, select the document with which you want to create the relation. 5. In the Relation type list, select a relation type. 6. Select Reverse relation if you want to create a child-parent relationship. If you started with the parent document highlighted and browsed for the child document to relate, leave this option blank. 7. Click OK. The related document appears in the Relations widget. 20

21 Create Documents File Naming and Versioning The document name is automatically assigned based on the naming schema: <artifact type> - <document ID> Where the artifact name is 230 characters and the document ID is a 9 digit incremental number. The naming rules ensure that documents are named consistently. For example, for a Governance and Procedures document, when the GMP group name is Directive, the GMP subgroup name is Facility, and the document ID is , the name displayed in the D2 Client workspace is: DIR Document versions are minor (v 0.1) until they are made effective. Documents in an Effective or Approved state have major version numbers (v 1.0). Importing a File from your Computer 1. Select Import > File from the menu bar. You can also drag and drop a file from the desktop or another location on your computer into the Doc List widget. 2. In the Import File dialog box, select the document to import from your local file system. 3. Select the file format and click Next. 4. In the Creation profile field, select a document category. 5. In the Group field, select a GMP group. 6. In the Subgroup field, select a GMP subgroup and then click Next. 7. On the Classification tab, select or type the required information. 8. Select or type information in the remaining tabs and click Next. 9. Click Check In and Finish to import the document. The uploaded document has a status of Draft and a version of 0.1. Document Updates This section contains the following topics: Editing a Document, page 21 Checking in a Document, page 22 Editing a Document 1. Log in as a member of the Author group. 2. In the Doc List, locate the document. 21

22 Create Documents Note: You can only edit a document that was created within the system and not imported files, which are scanned copies of documents and cannot be edited. 3. Right-click the document and select Edit. The document is checked out to the user. 4. Update, save, and close the document. Checking in a Document 1. In the Doc List, locate the document. 2. Right-click the document and select Check in. The document is checked in and can be added to a workflow. Related topic: Adding a Document to a Workflow, page 47 Configuring Content Templates The content for a newly-created document is based on a content template. Depending on the document that a user creates, Documentum Q&M automatically selects one or more appropriate content templates. A member of the template authors group for a specific domain can create or modify content templates for that domain. The artifacts (document types) that a template author assigns to a content template control the templates that are available to users when documents are created. When a content template is created the version of 0.1 is assigned with status set to Draft. The template author can then send the document to the template approvers of the corresponding domain for approval. Only the Approved versions of templates are available for selection when users create a new document. When configuring document templates, review for information on the fonts that appear correctly in PDFs. The fonts used must be available on the client machines and the Rendition Server. The Rendition Server embeds the fonts into the PDF. When Adobe Acrobat cannot find the fonts specified in the content template, it generates a message that warns the user that it is using alternative fonts in the PDF version. This problem can cause information loss or reformatting issues. Avoid these issues by using fonts that are compatible with Adobe Acrobat. The following table lists the content templates that are included in Documentum Q&M: Documents Governance and Procedure forms Governance and Procedure documents Manufacturing documents Packaging and Labeling documents Project documents Reference and Training documents Content Templates Form Template.doc Governance and Procedure Template.doc Manufacturing Template.doc Packaging and Labeling Template.doc Project Template.doc Reference and Training Template.doc 22

23 Create Documents Documents Validation documents Change Requests Topics in this section include: Creating a Content Template, page 23 Modifying a Content Template, page 23 Content Templates Validation Template.doc Change Request Template.doc Creating a Content Template 1. Log in as a member of the template author group for a particular site (for example, cd_boston_template_author). 2. Select Import > File from the menu bar. 3. On the Select files page, select a file to import, and click Next. 4. On the Fill creation profile page, in the Creation profile field, select GMP Template Management. 5. In the Document Type field, select Content Template and click Next. 6. On the Edit Properties page, type a name for the template in the Name field. 7. In the Applicable Artifacts area, select artifacts (document types) to use for the template from the List Assistance dialog box, and click OK. This template will be available for selection when documents with listed artifacts are created. 8. Click Next. 9. Edit the content, if necessary, and click Check In and Finish. The content template appears in the Templates/D2 folder. Modifying a Content Template You can modify a content template and the artifacts associated with the template. The artifacts that you assign to the content template control the templates that appear to users when they create a document. 1. Log in as a member of one of the Coordinator groups. 2. In the Browser, navigate to the Templates > D2 folder. 3. Right-click the content template and select Edit to adjust the template in its native format. 4. Exit, save, and check in the template. 5. To adjust the applicable artifacts, right-click the content template and select Properties. 6. In the Properties dialog box, adjust the selected applicable artifacts. 7. Click OK to update the content template properties. 23

24 Create Documents Configuring Dictionaries and Taxonomies Documentum Q&M stores product, material, equipment, and packaging and label information in taxonomies and dictionaries instead of registration forms, which is then inherited by the documents that you create. The following taxonomies are provided in Documentum Q&M that you can define and modify according to your requirements: GMP Artifacts GMP Artifacts by Group GMP Drug Products GMP Drug Substance GMP Drug Substance by Product GMP Equipment GMP Material GMP Package and Label GMP System Each taxonomy includes various dictionaries that you can use to define the taxonomy levels according to your requirements. For example, the GMP Drug Products taxonomy includes dictionaries such as product name, generic name, trade name, dosage form, dosage levels, product code, and so on. You can select the dictionary values from each of the dictionaries and create your specific GMP Drug Product taxonomy. Business Administrators can administer these taxonomies and dictionaries directly through Documentum Q&M using the following procedure: Configuring Taxonomies 1. Log in as a member of the Administrator or Coordinator group. 2. Click Administration. 3. Under Taxonomy Administration, double-click a taxonomy that you want to configure. 4. In the Taxonomy Properties dialog box, under Available values & structure, modify the existing taxonomy structure or create a new taxonomy by selecting the relevant values. 24

25 Create Documents In the right pane, the top of the list is the top level of the taxonomy structure. Below it is the second level of the structure and so on. For example, in the above image, GMP Drug Products is the top level of the taxonomy, AdvaEMC is the second level, Avadine is the third level, and so on. You can have multiple values at each level of the taxonomy structure except at the top level. 5. To create the taxonomy structure, select the top level value in the right pane. A list of dictionary values appear in the left pane. 6. To add the second level to the taxonomy structure, from the left pane, select a value and click the send to right button. If you want to include all the dictionary value, click the send all to right button. For example, when you select GMP Drug Products in the right pane, AdvaEMC appears in the left pane if it not already added to the taxonomy structure. Select it and click the send to right button. AdvaEMC is added as the second level of the GMP Drug Products taxonomy structure. 7. In the right pane, select the second level value of the taxonomy structure. A list of dictionary values appear in the left pane. 25

26 Create Documents For example, select AdvaEMC and then select Adavine in the left pane and click the send to right button. Adavine is added as the third level of the GMP Drug Products taxonomy structure. 8. Repeat step 6 to create the third level of the taxonomy. 9. Repeat steps 6 8 to create additional levels of the taxonomy. 10. To remove a level from the taxonomy structure, in the right pane, select a value and click the send to left button. To remove all of the values, click the send all to left button. 11. Click OK. Configuring Dictionaries 1. Log in as a member of the Administrator group. 2. Click Administration. 3. Under Dictionary Administration, double-click a dictionary that you want to configure. 4. In the Dictionary Properties dialog box, in the Languages tab, add dictionary values. 26

27 Create Documents 5. To exclude a dictionary value from being used, clear the check box next to that dictionary value. 6. Click OK. 27

28 Create Documents 28

29 Chapter 4 Request and Track Document Changes This section is for Readers and Authors who request and track document changes. This section contains the following topic: Change Requests, page 29 Change Requests In order to conform to GMP standards, pharmaceutical manufacturers are obliged to establish and maintain procedures that enable and demonstrate control over GMP documentation. Approving and tracking the creation of a new document and changes to existing Effective documents (including obsolete) are critical elements of document control procedures. Change Requests help manufacturers maintain a record of the changes made to documents. Authors or Coordinators can create Change Requests (CRs) to create new Category 1 documents or to propose changes to existing Category 1 documents. Any Category 1 document that needs to be revised or made Effective must be associated with a respective Change Request that is in the Change in Progress (CIP) state. Processing a Change Request, page 44 provides more information about the lifecycle states of a Change Request. A Change Request is subject to review and approval, and includes a description of the change, identification of the affected documents, the signature of the approving individuals(s), the approval date, and the date when the change becomes effective. Change Requests have their own permissions, lifecycles, and workflow. The following diagram shows the process flow for Change Requests: 29

30 Request and Track Document Changes Coordinators and Authors can create a Change Request without selecting any document. However, a Change Request must be available in the system if you want to send a Category 1 document to a workflow. After the Change Request is created and converted to a virtual document, you can add 30

31 Request and Track Document Changes Category 1 documents to the Change Request as child documents. The following conditions apply when attaching documents to a Change Request virtual document: The document being attached is not already attached to another open Change Request. The Effective version of the document to be revised is not associated to another Change Request that is in any status other than Closed. The Change Request is in the Draft or For Review state. The document is assigned to Category 1 lifecycle. The following image shows the Change Request virtual document with child documents: Related topics: Creating a Change Request, page 31 Attaching Documents to a Change Request, page 32 Processing a Change Request, page 44 Creating a Change Request 1. Log in as a member of the Author group based on the type of document. 2. Select New > Content from the menu bar. 3. In the Creation profile field, select Change Request. 4. In the GMP Categories field, select Change Request and click Next. 5. On the Edit properties page, fill in the required information: a. Change Request Info: Select or type the required information. Provide a title for the Change Request and a reason for the request. You can assign the Change Request to multiple sites by assigning them in the Applicable Sites field. b. Process Info: Note that the Control Category is 0. The fields on this tab are non-editable. c. Click Next. 6. If prompted, select a location for the document on your local file system. 7. In the Change Request document in Microsoft Word, type the details of the proposed changes and then save and close the Change Request. 8. Click Check In and Finish. The system creates a Draft version of the Change Request and places the document in the Change Request cabinet under <Applicable_Site> > Draft folder. 31

32 Request and Track Document Changes 9. To view the Change Request in the Change Request widget, right-click the Change Request and click Display virtual document. Attaching Documents to a Change Request Follow this procedure to attach or relate additional documents to a Change Request before you submit it for implementation. 1. Select the Change Request widget. 2. In the Doc List, navigate to the Category 1 document that you want to attach to the Change Request. Note: Category 1 documents cannot be sent to a Review/Approval workflow if they are not attached to a Change Request. In addition, the Change Request must be in the CIP state. However, Category 1 documents can be sent for collaborative editing and can be versioned without an associated Change Request. If you have a document selected when you create the Change Request, the document is automatically added as a child to the Change Request. 3. Select and drag the document to the Change Request widget. You can add multiple documents to the widget. Alternatively, you can right-click the Change Request and use the Add child option to add documents to the Change Request. 4. Right-click the Change Request and click Check in. 5. Right-click the Change Request and click Properties. 6. On the Affected Documents tab, select the values for each of the fields, and then click OK. Closing a Change Request The closing of a Change Request occurs after the Change Request has been approved (in CIP status) and all of the child documents have completed their individual lifecycles. The system automatically closes the Change Request when all of the child documents are in Effective states. However, if desired, you can manually close the Change Request using the following steps: 1. Log in as a member of the Coordinator group. 2. In the Change Request cabinet, navigate to the CIP folder for a specific site. 3. In the Doc List, right-click the Change Request and click Close Change Request. 32

33 Working with Documents Chapter 5 This section is for those who audit quality and manufacturing documents. This section contains the following topics: Locating Documents, page 33 Finding Documents using a Public Search, page 33 Finding Documents using Facets, page 34 Viewing Documents and their Properties, page 34 Viewing the Document History, page 34 Deleting and Restoring a Document, page 35 Exporting the Doc List to Microsoft Excel, page 35 Find Documents, page 36 Additional Menu Functions, page 37 Locating Documents The Browse view shows the folders and documents to which you have access. The folder structure is based on the sites, groups, and subgroups for the specific document category. When you select a folder in the Repository browser, the documents within that folder appear in the Doc List. You can perform quick searches by typing text to locate documents. For example, if you type Directive, the search returns all documents containing Directive. You can export your search results lists to Microsoft Excel. Finding Documents using a Public Search 1. Click the Browse button. 2. Click the My Searches tab. 3. In the Searches > Public Searches folder, double-click a search query, such as the Find Effective / Final Documents search query. 33

34 Working with Documents 4. Complete the required search fields and click Run. Finding Documents using Facets The faceted navigation includes two components, a Facet widget and a breadbox in the Doc List widget. The Facet widget allows search refinement in a dynamic facet list. Facets are grouped by category and ordered based on the configuration or advanced search settings. The Doc List widget contains the breadbox to display the facet selections in the same order it is used for refinement. The breadbox is hidden if no facet value is selected or if all the values are cleared. The facets are categorized as standard and structured facets. The standard facets are single selection facets. The structured facets are hierarchical. When a user selects a facet value in the Facet widget, all the facets are refreshed, the selected category reflects the selected facet value and removes the other facet values. A new set of facets available for the new results is displayed. The EMC Documentum D2 User Guide provides more information about using faceted search, the search ratings, and results. To perform a faceted search: 1. Click Browse. 2. Click the Doc List widget. 3. In the Quick Search box, type the name of the document you want to search and click Search. 4. Click the Facet widget to view the faceted search results. Viewing Documents and their Properties 1. To view the document without downloading it to your computer, select a document in the Doc List and click Preview. 2. To view the document properties, click the Properties tab next to the Preview. 3. To download a copy of the document to your computer, double-click it or click Content > Export from the menu. Viewing the Document History The document history, also known as the audit trail, shows information on what has happened to the document. It includes lifecycle state changes (such as changing from Draft to Effective (Effective or Approved) and any document property value changes. 1. Click the Browse button and select a document. 2. Click the Audit tab. The audit trail shows relevant information for the selected document. 34

35 Working with Documents Deleting and Restoring a Document To delete a document in D2 Client, you must install the D2-Bin plugin, which adds recycling bin capabilities to D2 Client. The EMC Documentum D2 Installation Guide provides the steps for installing the plugin. Follow these steps to delete and restore a document: 1. Log in as a member of the Author or Document Coordinator group. 2. Click Browse. 3. In the Browser, navigate to the folder containing the document you want to delete. 4. In the Doc List, right-click the document that is in the Draft state and click Delete. 5. In the Delete dialog box, select one of the following options: Delete selected version only: Deletes the current version of the document. Delete all versions: Deletes all major and minor versions of the document. 6. Click OK. The document is deleted and placed in the Recycle Bin. 7. To restore a deleted document, in the Recycle Bin, right-click the document and click Restore. Note: Documents that are purged from the Recycle Bin cannot be restored. Only users in cd_admingroup can purge the Recycle Bin. Exporting the Doc List to Microsoft Excel You can export the list of files in the Doc List to a Microsoft Excel spreadsheet. 1. Right-click the Doc List tab and select Export to Excel. 2. Select a location for the file on your local file system. 35

36 Working with Documents Find Documents Field settings on the Classification tab in the Properties dialog box determine the folders in which the solution stores documents. Because the directory structure is multi-layered, use the Documentum D2 search methods described in the EMC Documentum D2 User Guide or the searches that are specific to Documentum Q&M to find documents. You can find the queries specific to Documentum Q&M in the Searches > Public Searches folder. The reports are run as the logged-in user, and only display documents to which the user has access, based on user role and current status of those documents. For example, users, such as Document Auditors and Inspectors, do not have access to Draft documents. Other users, such as Document Authors, Reviewers, and Approvers, can access work-in-progress documents. Therefore, the same report can show different results depending on the user executing the report. The following table describes the Documentum Q&M search queries: Query name Find Completed TBR for a User Find Effective / Approved Documents Find Effective / Approved Documents by Domain Find My Documents Find My Documents that have Change Request by Document Coordinator Find Outstanding Task Participants Find Outstanding TBR Documents Find Outstanding TBR Recipients Find Outstanding TBR for a User Description Provides audit trail information about all TBR tasks completed by the specified user. Type the first few characters of the user name and select the user from a filtered list of users. Finds documents in an Effective or Approved lifecycle state based on a specified product and keyword. Finds documents in an Effective or Approved lifecycle state based on the domain of the document and an optional keyword. Finds documents in which the current user is an Author or Document Coordinator. Users can specify a keyword to filter the results. Only Authors or Document Coordinators can run this query and find documents. Finds the open Change Requests by the selected Document Coordinator. Any user, except Readers and Recipients, can run this query and find documents. Finds users that have not completed a task on a document that is currently in a workflow. Finds documents that are still awaiting sign-off from users in the TBR Distribution List. Document Coordinators can use this query to locate documents in a TBR workflow. Finds users that have not completed a TBR task on a document. Finds pending TBR tasks assigned to a specified user. Type the first few characters of the user name and select the user from a filtered list of users. 36

37 Working with Documents Query name Show Current Workflow Progress Find Delete Audit Events Description Shows a list of workflow tasks for all running workflows for the selected document. Shows a list of documents that were deleted. A TBR Status by Document report is available in PDF format. It contains completed and outstanding TBR information for a document. To run a consolidated PDF report, right-click a document (with a PDF rendition) and select View through C2 > TBR Audit Report. Additional Menu Functions In addition to the standard Documentum D2 menu functions (Checkout, Edit, Check in, Cancel Checkout, and so on) and the lifecycle state transition functions described in the lifecycles, the following additional menu functions are available. These functions do not change the status of the selected object. The following table describes the additional menu functions for Control Category 1-3 documents: Document menu function Purge interim versions Update Planned Effective Date Description Removes all historic versions of the document that are in the Draft, For Review, For Approval, or Withdrawn state. It does not remove the current version. This function is available with the selection of the current version and is restricted to the Document Coordinators and Authors of the document. Enables Coordinators to set a planned effective date for Category 1 documents that are in the Release Pending state. 37

38 Working with Documents 38

39 Review and Approve Documents Chapter 6 This section is for Authors, Document Coordinators, Reviewers, and Approvers who participate in the review and approval of documents. This section contains the following topics: Workflow Process, page 39 Document Review and Approval, page 47 Performing Tasks in a Workflow, page 48 Processing Documents in a Workflow, page 51 Working with Effective or Approved Documents, page 59 Viewing Document Status, page 61 Viewing Workflow Progress, page 62 Workflow Task Performer Changes, page 62 Workflow Process A workflow is a series of tasks that users perform on documents. Tasks appear in their inboxes with documents and instructions on how to complete the tasks. For example, an author starts a workflow by sending a document to one or more reviewers using a review workflow. When the workflow starts, the system automatically sends the document to all the specified reviewers to perform a review task. Each reviewer receives a review task. When all the reviewers finish their tasks, the workflow ends. The workflow creates separate tasks for each user participating in the workflow. There are two main types of workflow users: Workflow task performers: These users complete tasks in a workflow. Workflow supervisors: These users initiate the workflow. Workflow supervisors are usually Authors or Document Coordinators. The Life Sciences solution assigns the internal flag (category) to all documents to control applicable lifecycle and workflows. The document type determines the workflows that can be initiated for a document based on the category. The following table describes the document control categories: 39

40 Review and Approve Documents Control Categories Category 1 (Cat 1) Category 2 (Cat 2) Description Controlled documents that require formal review and approval along with signoff by the Quality Organization (QO). Controlled documents that require formal review and approval. They do not require signoff by the Quality Organization. Category 3 (Cat 3) Controlled documents that Authors can self-approve. Cat 3 documents do not require formal review and approval. Authors can act as Document Coordinators on Cat 3 documents. Documentum Q&M uses the following workflows for controlled documents: Workflow Submit for Collaborative Editing GMP Review Approve Site Performers (Submit for Review and Approval (Category 1)) Description Sends a document to a group of Reviewers for initial feedback or collaborative authoring. The Reviewers coauthor the document and edit the document at the same time. Authors can incorporate the changes into the document and make additional revisions. Sends a document for formal review and approval. A Reviewer can sign off on the document by accepting the task or reject it by annotating the document and sending it back to the Author for correction. If a document has annotations, the system auto-rejects the document and sends it back to the Author in the Draft state. After the Reviewer accepts the task, the document goes to the Approvers and then to the QO Approvers. These Approvers can approve the document or send it back to the Author. If the Approver rejects a reviewed document, the document returns to the Author in the Draft state. After the Author accepts the task and makes the required changes to the document, the Author can skip the review task and send the document directly to the Approver for approval. Approvers must electronically sign off on the document depending on the type of document. An Author cannot be an Approver on the same document. After all the reviewing and approving tasks are complete, the document goes to the Document Coordinator. The Document Coordinator releases the document as the Effective version. 40

41 Review and Approve Documents Workflow GMP Approve Site Performers (Submit for Approval (Category 1)) Launch Periodic Review WF (Category 1) Description Sends a document directly for approval. There is no review task in this workflow. Approvers must electronically sign off on the document depending on the type of document. An Author cannot be an Approver on the same document. After all the approving tasks are complete, the document goes to the Document Coordinator. The Document Coordinator releases the document as the Effective version. Sends a Category 1 document that is in the Effective state for a periodic review. Documents in the Suspended state can also be sent for a periodic review. The workflow is triggered automatically on the defined periodic review date for the document or Document Coordinators can trigger the workflow by right-clicking the document and selecting the workflow menu option. When releasing the document as the Effective version, the Document Coordinator can set the periodic review start day and the review recipients. Only Document Coordinators can be set as the periodic review recipients. When the workflow is triggered on the specified date, the assigned Document Coordinator receives a workflow task and an notification to initiate the workflow. The Document Coordinator accepts the periodic review task and assigns the workflow participants, that is the Reviewers and the Authors, for the review of the document. The list of participants for Reviewers includes Reviewers, Approvers, QO Approvers, and Document Coordinators. The Reviewer can accept or reject the task. After the Reviewer accepts the task, the Reviewer electronically signs the document and the document version remains Effective and the new review dates are set. However, all the Reviewers in the list of participants must approve the document for it to remain Effective. If any of the Reviewers reject the document using the Review with Comments option, the Reviewers have to provide their reject comments in the Comments field and the document returns to the Author for acknowledgement. Rejecting the task does not create a new version of the document. The Author acknowledges the rejected task and addresses all the comments provided by the Reviewers. The comments can be seen in Task Notes widget after selecting the task. The Author makes the necessary changes and sends the document 41

42 Review and Approve Documents Workflow Description to the Submit for Review and Approval or the Submit for Approval workflow. After all the review/approvals tasks for the document are complete, the document becomes Effective and the next periodic review date for the document is set. Launch Withdrawal Workflow (Category 1) Sends a Category 1 document to a selected list of Approvers for approval before it is Withdrawn. The document must be attached to a Change Request in CIP status in order to be sent on this workflow. The Document Coordinator sends an Effective Category 1 document to this workflow after specifying the reason for the withdrawal and selecting the list of Approvers who need to participate in the workflow. The Approvers can accept the task or reject it. If the Approver accepts the task, the Approver must electronically sign off on the document and the document becomes Withdrawn. Note that all the Approvers participating in the workflow must accept the task to withdraw the document. If an Approver rejects the task, the document remains in the Effective state. GMP Review Approve Site Performers (Submit for Review and Approval (Category 2)) Sends a document for review and approval. A Reviewer can review the document by accepting the task or reject it by annotating the document and sending it back to the Author for correction. If a document has annotations, the system auto-rejects the document and sends it back to the Author in the Draft state. After the Reviewer accepts the task, the document goes to the Approvers. The Approver can approve the document or send it back to the Author. If the Approver rejects a reviewed document, the document returns to the Author in the Draft states. After the Author accepts the task and makes the required changes to the document, the Author can skip the review tasks and send the document directly to the Approver for approval. Approvers might have to electronically sign off on the document depending on its type. An Author cannot be an Approver on the same document. Category 2 documents do not require QO approval. GMP Direct Approve Site Performers (Submit for Approval (Category 2)) Sends a document for approval without a review. An Author cannot be an Approver on the same document. 42

43 Review and Approve Documents Workflow Send for Approval (Category 3) Description Sends a document to a delegated Approver for approval without a review. Reviewers are the delegated Approvers for the document. A Reviewer can review the document by accepting the task or reject it by annotating the document and sending it back to the Author for correction. If a document has annotations, the system auto-rejects the document and sends it back to the Author in the Draft state. Send to TBR distribution (Submit to To Be Read (TBR) recipients (Category 1)) Content Template Approval The Author receives a task to either make the document effective or to revise it and send it back to the Reviewer. (Optional) Notifies users that it is time to read a document. Use this workflow for documents that require users to understand a process or procedure before releasing the documents. Document Coordinators typically start this workflow. If a user is already a part of this workflow, that user cannot be assigned to another Submit to To Be Read recipients workflow for the same document. Sends a content template for approval. After creating the content template, the template Author sends the document to the template Approver for approval. The template Approver can approve the document or send it back to the Author. If the Approver rejects a document, the document returns to the Author in the Draft state. The Approver must electronically sign off on the document on approval. The following figure illustrates the typical order of the Documentum Q&M workflows: 43

44 Review and Approve Documents Processing a Change Request After you create a Change Request and associate Category 1 documents to it, you must send the Change Request to a Submit for Review/Approval or Submit for Approval workflow. Unless the Change Request is in the Change in Progress (CIP) state, the associated Category 1 documents cannot be sent to the Review/Approval workflows. The following diagram shows how a Change Request is processed when sent to a workflow, along with its lifecycle state transitions: 44

45 Review and Approve Documents The following table describes each state of the Change Request: State Draft Description The Change Request is created by the Author or Coordinator in the Draft status and has a minor version. The Change Request can be sent on a Collaborative Editing workflow to other (site) Authors and Coordinators or can be deleted (sent to recycle bin). A Draft Change Request can be sent to the Submit for Review Approval or Submit for Approval workflow. For Review In the Repository browser, Change Requests in the Draft state are placed in a Draft folder under the Change Request cabinet. The workflow initiator can send a document on a Review/Approval workflow and must assign reviewers. The Site Coordinators are the designated reviewers for the Change Request. Only one coordinator is required to pick up the task. The reviewer can accept the task and send the Change Request for Approval or reject it and send it back to the Author with comments. In the Repository browser, Change Requests are placed in the For Review folder under the Change Request cabinet. 45

46 Review and Approve Documents State For Approval Change in Progress (CIP) Description The Change Request is sent for Approval either by the Reviewer (from the For Review status) or by the requestor (from Draft status). The Approver needs to sign off on the document after approving it. In the Repository browser, Change Requests are placed in the For Approval folder under the Change Request cabinet. After the Change Request is Approved, a notification is sent to the users listed in the notification list with a task to acknowledge the Change Request. After the user acknowledges, the Change Request progresses to the CIP state and the workflow ends. A Coordinator can revert the Change Request to Draft from this state only if no child documents have reached their Effective state. If the Change Request has child documents, it remains in the CIP state until all affected child documents have reached the Effective state. Closed In the Repository browser, Change Requests are placed in the CIP folder under the Change Request cabinet. The system transitions the Change Request to the Closed state when all affected child documents have reached their Effective state. The system closes the Change Request through a lifecycle batch job that runs at regular intervals. The Coordinator can also manually close the Change Request through a menu option. When the Change Request is Closed, it is transitioned to a major version. A Closed Change Request is read-only and its state cannot be changed. In the Repository browser, Change Requests are placed in the Closed folder under the Change Request cabinet. There are three workflows that the Change Request can be sent on: Submit for Collaborative Editing: This workflow is available for all documents in the system including Change Requests. Submit for Review Approval: This workflow is typically used when the change requestor is not certain of who must approve the Change Request or if there is a document control group within the organization who must first review the Change Request before it is sent for approval. Submit for Approval: This workflow is typically used for minor changes and in organizations where a change requestor is permitted to send a Change Request directly to those who must approve it. 46

47 Review and Approve Documents Document Review and Approval Adding a Document to a Workflow, page 47 Self-approving a Document, page 47 Adding a Document to a Workflow When you add a document to a workflow, Documentum Q&M provides workflow options based on the document classification and the lifecycle state. 1. Log in as a member of the domain for one of the following groups: Control Category 1, 2, and 3: Author or Document Coordinator A Category 1 document cannot be sent to a workflow without first attaching it to a Change Request. In addition, the Change Request must be in the CIP state. Attaching Documents to a Change Request, page 32 provides more information. Change Requests: Author or Document Coordinator 2. Right-click a document and select (workflow name). Note: The document type determines the workflows that can be applied to the document. 3. In the Planning / Sending of workflow dialog box: a. On the Recipients tab, fill in the participant group fields. b. Click Notifications to type information about the document. The participants of the workflow review these Workflow notes as the document completes task processing. c. Click Attachments to add additional content required for processing workflow tasks. You can add multiple documents to the same workflow in the Workflow documents field. d. Click Planning and Follow-up to select a date for planning and following up on the task in the workflow. 4. Click Send to send the document to the specified user in the workflow. Self-approving a Document Authors can self-approve control category 3 documents. 1. In the Doc List, right-click a document and select Self-approve and make Effective/Approved/Final. 2. Fill in the fields, if required, and click OK. 47

48 Review and Approve Documents Performing Tasks in a Workflow As documents progress in a workflow, users are assigned tasks based on their role. For example, Reviewers perform reviewing tasks and Approvers perform approving tasks. Documentum Q&M provides defined groups for each role. In the workflows for controlled documents and Change Requests, task participants have five days to perform a task. Task participants receive messages in their Tasks inbox to remind them that a task requires attention. Messages are sent when the task is not performed in three days, a message notifies the task participant that they have two days to complete the task. Tasks that are not completed within two days are rejected. A message is also sent to the workflow initiator (usually the Author) that the task is not complete. The following actions are standard workflow actions for processing tasks: Acquire Task: Confirms that the user has read and received the task. Accept Task: Confirms that the task has been completed and its quality accepted. Depending on the type of workflow that is run, this label might vary. Reject Task: Confirms that the task is completed or its quality was not acceptable. Depending on the type of workflow that is run, this label might vary. Abort workflow: Closes the workflow. Administrators and the supervisor of a workflow can perform this task. The following table lists the respective default labels for accepting and rejecting a task in each workflow. Workflow and Step Collaborative Editing Accept Task Label (Positive Response) Step 1: Coauthor/Review Edits Complete NA Step 2: Primary Author Changes Consolidated NA Submit for Review and Approval (Category 1) Reject Task Label (Negative Response) Step 1: Content Review Reviewed Without Comments Reviewed With Comments Step 2: Approval Approve Reject Step 3: QO Approval Approve Reject Step 4: Coordinator Accept Task Reject Task Submit for Approval (Category 1) Step 1: Approval Approve Reject Step 2: QO Approval Approve Reject Step 3: Coordinator Accept Task Reject Task Submit for Periodic Review (Category 1) Step 1: Coordinator Assign Reviewers NA Step 2: Review Reviewed and No Revision Required Reviewed and Revision Requested 48

49 Review and Approve Documents Workflow and Step Step 3: Acknowledge Accept Task Label (Positive Response) Acknowledge Request For Revision Submit for Review and Approval (Category 2) Reject Task Label (Negative Response) Step 2: Review Reviewed Without Comments Reviewed With Comments Step 3: Approval Approve Reject Submit for Review and Approval (Change Request) Step 1: Review (Coordinator) Reviewed Without Comments Reviewed With Comments Step 2: Approval Approve Reject Step 3: Primary Author (Notify Users) Submit for Approval (Category 2) Acknowledge Request for Change Step 1: Approve Approve Reject Submit for Approval (Change Request) Step 1: Reviewer/Approver Approve Reject Step 2: Primary Author Acknowledge Request for Change Submit for Review Format Approval (Category 2) Step 1: Review Reviewed Without Comments Reviewed With Comments NA NA NA Step 2: Formatting Formatting Complete NA Step 3: Approval Approve Reject Submit for Review (Category 3) Step 1: Review Reviewed Without Comments Reviewed with Comments Submit for Approval (Category 3) Step 1: Approval Approve Reject The EMC Documentum D2 User Guide provides additional information on performing standard Documentum D2 tasks in a workflow. Related topics: Viewing the Audit Trail, page 50 Categorizing Inbox Tasks, page 50 49

50 Review and Approve Documents Viewing the Audit Trail Documentum Q&M audits events for controlled documents and change request documents. The system does not audit events for non-controlled documents. 1. Click Tasks to open the tasks view. 2. To view the audit trail for a task, navigate to the Workflow Task List, select a task, and then click the Audit tab. 3. To view the audit trail for a document, in the Task Attachment tab, select a document, and then click the Audit tab. 4. To export the report information in a portable format, right-click the Audit tab and select Export to Excel. Categorizing Inbox Tasks 1. Click Tasks. 2. Click the down arrow on the Workflow Task List tab and select Switch widget. 3. Select the Tasks browser widget. The tasks in the inbox appear in different categories. 50

51 Review and Approve Documents 4. In another area, add the Workflow Task List widget. For example, click the + tab (Add widget) next to the Task Attachment tab and select the Workflow Task List widget. 5. In the Tasks Browser, click a category to view the tasks in the Workflow Tasks List tab. Processing Documents in a Workflow The following topics describe how to process documents in a workflow: Collaborative Editing, page 52 Editing a Document in a Workflow, page 52 Consolidating Document Changes, page 52 Reviewing Documents in a Review Task, page 53 Reviewing Document Feedback from Reviewers, page 54 Approving Documents, page 55 Reviewing Document Feedback from Approvers, page 56 Acknowledging Change Requests, page 56 Releasing Control Category 1 Documents as Effective Versions, page 57 51

52 Review and Approve Documents Collaborative Editing In the Collaborative Editing workflow, Authors and Reviewers edit documents in the Editing: <document_name> task. The Author originating the workflow incorporates the changes into the document from the Reviewer feedback. When the Collaborative Editing workflow finishes, you can send the document to a review and approval workflow. Follow these procedures to edit documents: Editing a Document in a Workflow, page 52 Consolidating Document Changes, page 52 Editing a Document in a Workflow 1. Depending on the workflow, log in as a member of an Author, Reviewer, or Coordinator group. 2. In the Workflow Task List, select the task. 3. In Task Attachment, select the document and then select Content > Review and Edit Personal Copy from the menu bar. If the document contains annotations from others Reviewers, select Content > Review and Edit Consolidated Copy. You can verify if the document has annotations in the Relations tab. Note: D2 supports adding and editing annotations only in the Microsoft Word native format. The annotations functionality does not work for other formats such as Excel, PowerPoint, and so on. See the EMC Documentum D2 User Guide for more information about annotations. In Collaborative Editing workflow, when a document is opened in the Word 2013 native format during the Review phase, a Reviewer can disable the Track Changes feature in Word and modify the original content in the document. However, this negates the purpose of the collaborative editing as the other Reviewers in the workflow will not know if any changes were made to the document. As there is no option to lock the disabling of Track Changes in Word 2013, you must not disable Track Changes for documents opened in Word 2013 in the Collaborative Editing workflow. 4. Edit the document in its native format and save the changes. 5. Click Relations, right-click the document with annotations, and select Check in. 6. In the Workflow Task List, right-click the task, select Edits Complete, add a comment, and click OK. When the task is rejected, the document is routed to the Author (workflow initiator) in the Editing task. Consolidating Document Changes 1. Log in as a member of an Author group. 2. Click the Tasks button to open the tasks view. 3. In the Workflow Task List, select the task. 52

53 Review and Approve Documents 4. In Task Attachment, select the document and then select Content > Checkout and Merge Changes from the menu bar. 5. Edit the document in its native format, accept or reject the changes, and save the document. 6. Right-click the document, and select Check in. 7. Right-click the task and select Changes Consolidated. 8. In the Task dialog box, add comments and select one of the options: Select End Workflow to stop the workflow. Select Return the document to the Reviewers to continue editing the document. 9. Click OK. 10. If the document can be self-approved, right-click the document, select Self-approve and make Effective/Approved/Final, and click OK. If this option is not available, the document must be formally-reviewed and approved before it becomes Effective or Approved. Reviewing Documents in a Review Task In the Review tasks of the controlled document workflows. Reviewers review documents. The Author, who originates the workflow, reviews the feedback received from the Reviewers in a separate workflow task. 1. Log in as a member of a Reviewer group. 2. Click the Tasks button to open the tasks view. 3. In the Workflow Task List, select the task. 4. Select the document from the Task Attachment area. 5. To review and annotate the PDF document format: a. In the Task Attachment area, select the document, double-click the document and annotate the PDF. b. When you finish reviewing the document, save and close it. c. To check in the annotations, click Relations, right-click the document with annotations, and select Check in. 6. To annotate the document in its native format, for example, in Microsoft Word: a. In the Task Attachment area, select the document and then select Content > Review and Edit Personal Copy from the menu bar. If the document contains annotations from others Reviewers, select Content > Review and Edit Consolidated Copy. You can verify if the document has annotations in the Relations tab. b. Edit the document in its native format and save the changes. c. To check in the annotations, click Relations, right-click the document with annotations, and select Check in. 7. For Control Category 1 and 2 documents: 53

54 Review and Approve Documents a. After reviewing the document, in the Workflow Task List, right-click the task and select Reviewed Without Comments or Reviewed With Comments to demote the document to Draft and send a task to the Author for additional changes. b. If you accept the task, in the Sign off dialog box, type your login credentials and select a reason to electronically sign the document and click OK. The system records your intention in the audit trail of the document. The task is accepted and proceeds to the next task. 8. For Change Requests: a. To view the affected documents: i. In the Workflow Task List, select the task. ii. Select the document from the Task Attachment area. iii. Click the Affected Docs tab. b. After reviewing the document, in the Workflow Task List, right-click the task and select Reviewed Without Comments or Reviewed With Comments to the document to Draft and send a task to the Author for additional changes. c. Add a comment and click OK. The task is accepted and proceeds to the next task. d. To view the affected documents, click the Affected Docs tab. 9. For Control Category 3 documents, after reviewing the document, in the Workflow Task List, right-click the task and select one of the following options: Reviewed Without Comments: This option assigns Reviewed status to the document and makes it ready to be promoted to Approved. Reviewed With Comments: This option rejects the document and returns it to the Author in the Draft state. Reviewing Document Feedback from Reviewers When the Reviewers return a document to the Author (workflow originator) for further changes, the Author receives a task to review the document. The document reverts to the Draft state. The Author reviews and merges the comments and annotations from the Reviewers. The Review / Approval workflows for controlled documents and Change Requests contain Draft tasks. 1. Log in as a member of an Author group. 2. Click the Tasks button to open the tasks view. 54

55 Review and Approve Documents 3. In the Workflow Task List, select the task. 4. In the Task Attachment area, double-click the document to view any PDF annotations. 5. To merge native annotations from the Reviewers (for example, tracked changes in Microsoft Word): a. In the Task Attachment area, select the document and then select Content > Checkout and Merge Changes from the menu bar. b. Merge comments by accepting or refusing the modifications. c. Save and close the document. d. Right-click the document and select Check in. 6. For Control Category 1 and 2 documents, right-click the task and select one of the following options to complete the task: Select Resend to route the document back to the Reviewer or skip the review phase and send the document directly for approval. Select End Workflow to end the workflow. 7. For Control Category 3, right-click the task and select one of the following options to complete the task: Select Resend to route the document back to the Reviewer. Select End Workflow to end the workflow. Approving Documents In the Approval tasks, Control Category 1 documents require approval from the Approval and Quality Organization (QO) Approval groups. Control Category 2 documents and Change Requests require approvals from Approval groups. If the documents require a signature, all of the specified Approvers must sign off on the document. 1. Log in as a member of an Approver group for the formal review and approval workflows. 2. Click the Tasks button to open the tasks view. 3. In the Workflow Task List, select the task. 4. To review the document, in the Task Attachment area, double-click the document to view it in PDF format. 5. To reject the document and send it back to the Author, right-click the task and select Reject. 6. To approve the document, right-click the task and select Approve. a. For Control Category 1 and 2 documents, the Sign off dialog box appears. The document type determines whether an electronic signature is required for approval. Type your login credentials and select a reason to electronically sign the document. Click OK. The task is accepted and proceeds to the next task. b. For Change Requests documents, the Sign off dialog box appears. The signature page is at the end of the PDF rendition. The system automatically applies the signatures to the PDFs 55

56 Review and Approve Documents of the attached documents. Signing off on each attached document is not required. When completely approved, it forwards automatically to the Author for implementation. Type a comment and click OK. The task is accepted and proceeds to the next task. Reviewing Document Feedback from Approvers 1. Log in as a member of an Author group. 2. Click the Tasks button to open the tasks view. 3. In the Workflow Task List, select the task. 4. In the Task Attachment area, double-click the document to view any PDF annotations. 5. In the Task notes, double-click the note from the Approver. 6. In the Workflow Note dialog box, review the comments from the Approver and then click Close. 7. To make changes to the document, in the Task Attachment area, select the document and then select Content > Checkout and Merge Changes from the menu bar. 8. Edit the document in its native format and save the document. 9. Right-click the document, and select Check in. 10. Right-click the task and select one of the following options to complete the task: Select Resend to route the document back to the Approver or Reviewer. Select Promote to For Review to send the document to Reviewers. Select Promote to For Approval to skip the review task and send the document directly for approval. Select End Workflow to complete the workflow and retain the document in the Draft state. Acknowledging Change Requests 1. Log in as a member of the group assigned as the Acknowledger of the Change Request. 2. Click the Tasks button to open the tasks view. 3. In the Workflow Task List, select the task. 4. To review the document, in the Task Attachment area, double-click the document to view it in the PDF format. 5. To acknowledge the Change Request, right-click the task and click Acknowledge Request for Change. 56

57 Review and Approve Documents Releasing Control Category 1 Documents as Effective Versions Document Coordinators release Control Category 1 documents to an Effective state after all the review and approve tasks are complete. When there are multiple Document Coordinators, the first one to acquire the task must complete the task. Approvers and Document Coordinators are responsible for ensuring that the correct procedures have been followed before releasing the document. 1. Log in as a member of a Document Coordinator group. 2. Click the Tasks button to open the tasks view. 3. In the Workflow Task List, select a task that has a document that is ready to be made effective. In the Task Attachment area, the document shows a status of Release Pending. 4. Right-click the task and select Accept task. 5. Select one of the following options: Set dates and send for review (Sends the document to To Be Read users): Use this option to send documents to the TBR Distribution List for recipients to read the document. The document remains in a Release Pending state. After all the recipients confirm that they have read the document, the system notifies the Document Coordinator. At that time, the Document Coordinator can select Make Effective or Cancel document release and revert to Draft. Note: If you select this option, make sure that you add the TBR participants in the TBR Distribution List before proceeding. Set dates and do not send for review: Use this option to promote documents and make them Effective immediately. The document becomes available to Readers. 6. Type a comment and click OK. 7. On the Set document effectivity period tab, configure the effective period of the document as defined in the following table: Field Planned Effective date Description Select the date when the document becomes Effective. When the planned effective date is reached, a document that is in the Release Pending state and is not part of any active workflow and is not checked out, is automatically made Effective. This option is also available for Control Category 1 documents in the Update Planned Effective Date menu option. Effective from date Note: The planned effective date triggers the transition to Effective after a lifecycle batch is run. This batch can run on or after the planned effective date, that is, the actual effective date depends on the schedule of the lifecycle batch. The Planned Effective date field must not be left blank. Otherwise, the lifecycle batch will not pick up the document to transition. This date is set by the system by default when the document is made Effective and cannot be modified. 57

58 Review and Approve Documents 8. On the Set periodic review tab, configure the review period of the document as defined in the following table: Field Periodic Review Interval Periodic Review Due Date Periodic Review Start Days Periodic Review Recipients Description The review interval for the document. The periodic review interval is determined for each document type from the GMP Artifacts dictionary. This is typically a period of 2 or 3 years depending on the document type and company policy. If the periodic review interval value is set as blank or 0 in the dictionary, the Periodic Review workflow is not initiated on the document. When the document becomes Effective, the system automatically adds this interval to the Effective Date to determine the Periodic Review Due Date. The due date for the periodic review. This is determined by adding the Periodic Review Interval to the Effective Date. This option is also available for Control Category 1 documents in the Adjust Review Dates menu option. Updating the Periodic Review Date for a Document, page 61 provides the steps for adjusting the periodic review start date. Specify the start day for the periodic review. By default, it is set to 30 days. The Coordinator can determine how many days prior to the Periodic Review Due Date the periodic review workflow should be launched by the system by entering the Periodic Review Start Days. The user or group that receives the first task in the Periodic Review workflow and is required to assign reviewers for the second step in the workflow. Typically, the recipients will be Document Coordinators. 9. On the Set recipients and readers tab, specify the users who can read the document after it becomes effective, as defined in the following table: Field TBR Distribution List Readers Description (Category 1 documents) Select the users and groups who can read the document before it becomes Effective. The Send to TBR distribution workflow tracks users to ensure that they have read the document. If a user is already a part of the Send to TBR distribution workflow, that user cannot be assigned to another Send to TBR distribution workflow for the same document. Select the users to notify after the document becomes Effective. They can read the document while it is Effective. 10. Click OK. The document progresses based on the options selected in the previous steps. 58

59 Review and Approve Documents Working with Effective or Approved Documents This section contains the following topics: Suspending a Document, page 59 Withdrawing a Document, page 59 Superseded Documents, page 60 Setting the Planned Effective Date for a Document, page 60 Updating the Periodic Review Date for a Document, page 61 Suspending a Document Suspending an Effective or Approved document prevents it from being used while a modified version is being prepared, reviewed, and approved. You must be a Coordinator to perform this task. Suspended documents can be sent for a periodic review. 1. In the Doc List, right-click a document in the Effective or Approved state and select Suspend document. 2. Click OK. 3. To reinstate the document, select Reinstate as Effective/Final version. 4. In the Make document Effective/Approved/Final dialog box, click OK. Withdrawing a Document Category 1 documents in Effective state cannot be directly withdrawn. These documents require approval before being withdrawn and therefore, must be sent to the Launch Withdrawal Workflow. The document must be attached to a Change Request in the CIP state in order to be sent to this workflow. See Attaching Documents to a Change Request, page 32 for the steps. To withdraw Category 1 documents, follow these steps: 1. Log in as a Document Coordinator. 2. In the Doc List, right-click a document in the Effective state and select the Launch Withdrawal Workflow. 3. In the Withdrawal Reason field, type the reason. 4. In the Withdrawal Approvers field, list all the Approvers who need to review and approve the document for withdrawal. 5. Click OK. The Approvers receive the withdrawal task and can participate in the Withdraw workflow. Approving Documents, page 55 provides the steps for approving documents. After all the listed 59

60 Review and Approve Documents Approvers have accepted the task, the document becomes Withdrawn. It is not possible to reinstate a Withdrawn Cat 1 document to Draft or any other status. For Category 2 and 3 documents, you can retire documents in the Draft, Release Pending, or Approved states by withdrawing them. All versions are withdrawn together. You can retain withdrawn documents as historical records. You must be a Coordinator to perform this task. 1. Log in as a Document Coordinator. 2. In the Doc List, right-click a document and select Withdraw document. 3. In the Withdrawal Reason field, type the reason. 4. Click OK. 5. To reinstate a withdrawn document, select Revert to Draft. Superseded Documents Superseded documents are documents that were previously Effective or Approved. There is only one Effective or Approved version of a document at a time. The system automatically updates the document state when new Effective or Approved versions are created. For example: 1. Version 0.1: Process a document in a Submit for Review and Approval workflow. 2. Version 1.0: Document Coordinators change the document state to Effective or Approved. The version is Version 1.1: The document is edited and in a Draft state. 4. Version 1.1: Process a document in a Submit for Review and Approval workflow. 5. Version 2.0: Document Coordinators change the document state to Effective or Approved. The updated Effective or Approved document is version 2.0. The original document, which was version 1.0, is now automatically changed to Superseded. Users cannot suspend, withdraw, or change the version of a superseded document. They only have READ permission on the superseded document. They cannot check out or edit a superseded document (all non-current versions of a document). Setting the Planned Effective Date for a Document As the effective date is set by the system when a Category 1 document is made Effective, the system does not allow Site Coordinators to modify the effective date of the document. Instead, Coordinators can set a planned effective date for the document that is in the Release Pending state. When the planned effective date is reached, a document that is in the Release Pending state and is not part of any active workflow and is not checked out, then the document is automatically made Effective. 1. Log in as the member of the Document Coordinator group for a particular site. 2. In the Doc List, right-click a Category 1 document that has a status of Release Pending, and then click Update Planned Effective Date. 60

61 Review and Approve Documents 3. In the Set Planned Effective Date dialog box, in the Planned Effective Date field, set the required date. 4. Click OK. The Document Coordinator can make a document Effective before the planned effective date by right-clicking the document and selecting Make Effective Immediately. Updating the Periodic Review Date for a Document To conform to GMP standards, pharmaceutical manufacturers are required to periodically review GMP Category 1 documents to ensure that they remain current, applicable, and compliant with existing regulations. Different types of documents may have different review intervals but the most common review period is two years starting from the Effective date of the document. You can set the periodic review date and the list of reviewers for Category 1 documents in the Effective state by using the following steps: 1. Log in as the member of the Document Coordinator group for a particular site. 2. In the Doc List, right-click a Category 1 document that has a status of Effective and then click Adjust Review Dates. 3. In the Set Periodic Review Dates dialog box, in the Next Periodic Review Date field, select a date for the periodic review workflow to be launched. 4. In the Periodic Review Recipients field, add or remove the user or group that receives the first task in the Periodic Review workflow. Typically, the recipients will include only Document Coordinators. 5. Click OK. When the periodic review is triggered, the assigned Document Coordinators receive a system notification to initiate the periodic review process for the document. The Document Coordinator can also manually launch the periodic review workflow by right-clicking the document and selecting the workflow menu option. Viewing Document Status Users can view the progress of a document in the document properties. 1. In the Doc List, locate the document. 2. Right-click the document and select Properties. 3. On the Process Info tab, you can view the control category of the document and its status. 4. Click Cancel. 61

62 Review and Approve Documents Viewing Workflow Progress Authors and Document Coordinators can monitor the progress of document workflow tasks. 1. Log in as a member of a Document Coordinator or Author group. 2. Select a document in the Doc List and click Workflow overview. 3. Expand the workflow to view the workflow tasks. Active workflows and tasks show a Running state. Workflow Task Performer Changes After a workflow starts, it is often necessary to change the performer of a workflow task. For example, a reviewer may not be available to complete a review inbox task. In this case, the reviewer can delegate the task to another workflow task performer. Workflow task performers can delegate the tasks in their inboxes to other workflow task performers. Workflow supervisors can change the workflow task performers in the following ways: Delegate a task that is in the inbox of any workflow task performer. For example, a workflow supervisor can delegate a task because an employee left the company or is out of the office on sick leave. You can delegate only the tasks that are in the inbox of workflow task performers, not future tasks. Stop a workflow and send a document to a new workflow to add additional performers to a current task. For example, a workflow supervisor sends a document to the Review workflow and the workflow creates a task for Reviewer 1. The workflow supervisor can stop the workflow and then resend the document for review to Reviewers 1, 2, and 3. 62

63 Review and Approve Documents There are two sets of performers for a document. One set is the performers defined on the Process Info tab of the document properties. The other set is the performers that actually participate in the workflow. When a workflow starts, the workflow task performers are set based on the performers listed on the Process Info tab. Any change in the workflow performers using the Update performers, Send to workflow, or Reassign Roles menu options changes only the actual workflow performers. It does not change the performers shown on the Process Info tab. These workflow performers have access to the documents only when they are the current performers, that is, they have a task in their inbox. 63

64 Review and Approve Documents Updating Workflow Task Performers 1. Log in as a workflow supervisor. Note: The workflow initiator and Coordinators can update the workflow performers for active (acquired or not) and future tasks. 2. Navigate to the document for which you are updating performers. 3. In the Doc List, select the document and click Workflow overview. If you do not have a Workflow overview tab, click the + tab and select the Workflow overview widget. 4. In the Workflow overview, right-click a workflow with a state of Running and select Update performers. 5. Update the performers as needed and click OK. You can only update performers for tasks that are not active. For example, if a document is on a review/approval workflow and is in For Review phase, you cannot change the Reviewers but you can change the Approvers. Stopping a Workflow 1. Log in as a workflow supervisor. 2. Navigate to the document for which you want to stop the workflow. 3. In the Doc List, select the document and click Workflow overview. 4. In the Workflow overview, right-click the workflow you want to stop and select Abort workflow. 5. Click OK. The workflow state changes from Running to Aborted. Delegating a Task as a Workflow Supervisor 1. Log in as a workflow supervisor. 2. Navigate to the document for which you are delegating a task. 3. In the Doc List, select the document and click Workflow overview. If you do not have a Workflow overview tab, click the + tab and select the Workflow overview widget. 64

65 Review and Approve Documents 4. In the Workflow overview, expand the workflow, right-click the user whose task you want to delegate, and select Delegate task. 5. In the From the user field, select the user whose task you want to delegate. 6. In the To the user field, select the user to receive the task and click OK. Delegating a Task as a User All workflow users can delegate their tasks to another workflow performer. 1. In the Workflow Task List, locate a task to delegate. 2. Right-click the task and select Delegate task. 3. In the User field, select the user to receive the task and click OK. Reassigning Roles 1. Log in as a member of a Document Coordinator or Author group. Only document coordinators can reassign roles for Category 1 and 2 documents. Authors and document coordinators can reassign roles for Category 3 documents. 65