EMC Documentum Quality and Manufacturing

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1 EMC Documentum Quality and Manufacturing Version 3.1 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... 7 Chapter 1 Overview... 9 Quality and Manufacturing... 9 Quality and Manufacturing Document Management Chapter 2 Roles Site-Based User Roles Authors Reviewers Approvers Coordinators Readers and Recipients Auditors Administrators Chapter 3 Create Documents Controlled Documents Creating a Controlled Document File Naming and Versioning Importing a File from your Computer Document Updates Editing a Document Checking in a Document Configuring Content Templates Modifying a Content Template Configuring Dictionaries and Taxonomies Chapter 4 Request and Track Document Changes Change Requests Creating a Change Request Attaching Additional Documents to a Change Request Chapter 5 Review and Approve Documents Workflow Process 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

4 Table of Contents Processing Documents in a Workflow Document Editing Editing a Document in a Workflow Incorporating Document Changes Reviewing Documents in a Review Task Reviewing Document Feedback from Reviewers Reviewing and Approving Change Request Documents Reviewing Authorized Change Request Documents Approving Documents Releasing Control Category 1 Documents as Effective Versions Working with Effective Documents Suspending a Document Withdrawing a Document Superseded Documents 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 6 Working with Documents Locating Documents Finding Documents using a Public Search Viewing Documents and their Properties Viewing the Document History Exporting the Document List to Microsoft Excel Find Documents Chapter 7 Print and Export Documents Printing a Control Category 1 Document Exporting Control Category 1 Documents Chapter 8 Document Control Control Categories Change Request Control User Roles Cross-functional User Groups Document Lifecycle Models Control Category 1 Documents Lifecycle Control Category 2 Documents Lifecycle Control Category 3 Documents Lifecycle Control Categories Additional Menu Functions Permissions Control Categories 1-3 Document Permissions Change Request Document Permissions Chapter 9 Workflows For Collaborative Editing (Categories 1-3)

5 Table of Contents Submit for Review / Approval (Category 1) Submit for Review / Approval (Category 2) Submit Directly for Approval (Category 2) Submit for Review (Category 3) Submit to To Be Read recipients (Category 1) Recall Document (Category 1) Submit Change Request Chapter 10 Troubleshooting Verifying User Roles Connection Issues

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7 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 June 2016 Description Added a note about annotations not supported in Excel on PowerPoint native formats in Editing a Document in a Workflow, page 40. 7

8 Preface Revision Date February 2016 October 2014 Description Updated the description in Recall Document (Category 1), page 79. Initial publication 8

9 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 9 Quality and Manufacturing Document Management, page 11 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 9

10 Overview 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. EMC Documentum Quality and Manufacturing 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: 10

11 Overview Related topic: Quality and Manufacturing Document Management, page 11 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 Final and policy and procedure documents have a status of Effective. 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 Reviewer, a QO Approver, and a Document Coordinator. The Document Coordinator manages the release of the documents by making them effective (final). The following figure illustrates an example of the highest-level review and approval process: 11

12 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, Final, and Withdrawn documents to assist them with their audits. 12

13 Roles Chapter 2 Documentum Q&M provides defined user roles that enable or restrict user access to documents and information in the system. This section contains the following topics: Site-Based User Roles, page 13 Authors, page 14 Reviewers, page 14 Approvers, page 15 Coordinators, page 15 Readers and Recipients, page 16 Auditors, page 16 Administrators, page 17 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 Administration Guide provides more information about adding site-based user roles. 13

14 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 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 19 Import controlled documents Importing a File from your Computer, page 21 Send a document for collaborative editing Adding a Document to a Workflow, page 35 Send a document for review and approval Adding a Document to a Workflow, page 35 Self-approve documents Self-approving a Document, page 36 Edit a document in a collaborative editing workflow Incorporate document changes from each reviewer Review document feedback from reviewers Implement authorized change requests Editing a Document in a Workflow, page 40 Incorporating Document Changes, page 41 Reviewing Document Feedback from Reviewers, page 43 Reviewing Authorized Change Request Documents, page 44 Work with Effective documents Working with Effective Documents, page 47 View the document history Viewing the Audit Trail, page 37 View document status Viewing Document Status, page 48 View workflow progress Viewing Workflow Progress, page 48 Change workflow task performers Workflow Task Performer Changes, page 49 Find documents using Public searches Find Documents, page 55 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: Task Instructions Performing workflow tasks Performing Tasks in a Workflow, page 36 14

15 Roles Task Participate in the collaborative editing of documents Instructions Editing a Document in a Workflow, page 40 Review and annotate documents Reviewing Documents in a Review Task, page 41 View document status Viewing Document Status, page 48 Delegate a task to another user Delegating a Task as a User, page 51 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 36 Approving documents Approving Documents, page 44 Reviewing and approving Change Requests Reviewing and Approving Change Request Documents, page 43 View document status Viewing Document Status, page 48 Delegate a task to another user Delegating a Task as a User, page 51 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 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 Manage the release of documents Instructions Releasing Control Category 1 Documents as Effective Versions, page 45 Working with Effective Documents, page 47 View the document history Viewing the Audit Trail, page 37 15

16 Roles Task Instructions View document status Viewing Document Status, page 48 View workflow progress Viewing Workflow Progress, page 48 Change workflow task performers Workflow Task Performer Changes, page 49 Find documents using Public searches Find Documents, page 55 Create controlled documents Creating a Controlled Document, page 19 Import controlled documents Importing a File from your Computer, page 21 Send a document for collaborative editing Adding a Document to a Workflow, page 35 Send a document for review and approval Adding a Document to a Workflow, page 35 Self-approve documents Self-approving a Document, page 36 Edit a document in a collaborative editing workflow Incorporate document changes from each reviewer Review document feedback from reviewers Editing a Document in a Workflow, page 40 Incorporating Document Changes, page 41 Reviewing Document Feedback from Reviewers, page 43 Readers and Recipients Readers have read-only access to Effective versions of documents. They browse for, search, and read documents. Recipients 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. 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 36 Delegate a task to another user Delegating a Task as a User, page 51 Auditors Auditors have read-only access to audit logs as well as Effective, Final, Superseded, and Expired documents. They can view document content, history, and properties. The following table lists Auditor tasks and provides links to the instructions: 16

17 Roles Task Instructions Browse and search for documents. Locating Documents, page 53 Finding Documents using a Public Search, page 53 View the document history Viewing the Document History, page 54 View document properties Export content to Microsoft Excel Viewing Documents and their Properties, page 54 Exporting the Document List to Microsoft Excel, page 54 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 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. 17

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19 Create Documents Chapter 3 This section is for Authors who create documents. This section contains the following topics: Controlled Documents, page 19 File Naming and Versioning, page 21 Importing a File from your Computer, page 21 Document Updates, page 22 Configuring Content Templates, page 22 Configuring Dictionaries and Taxonomies, page 24 Controlled Documents EMC Documentum Quality and Manufacturing 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 topic: Creating a Controlled Document, page 19 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. 5. In the Group field, select a GMP group. 6. In the Subgroup field, select a GMP subgroup and then click Next. 19

20 Create Documents 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 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. 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 Documentum 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. 20

21 Create Documents Related topic: File Naming and Versioning, page 21 File Naming and Versioning The document name is automatically assigned based on the naming schema: <artifact type> - <document ID> The naming rules ensure that documents are named consistently. Where the artifact name is 230 characters and the document ID is a 9 digit incremental number. 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 , then the name displayed in the D2 Client workspace is: DIR Caution: The system generates the document_id from a 9-digit counter, which allows 100 million unique document IDs. In D2 Config, the size of the counter can be increased by editing the _Document_ID auto naming configuration. However, the document_id attribute in the cd_controlled_doc object type is a ten character string. When the digits are increased above 10, the cd_controlled_doc object type must also be changed. If the counter value on the _Document_ID auto naming configuration is reset after creating documents, subsequent document IDs might not be unique and can cause serious system issues. Consequently, you should not reset this counter value in a production repository. Document versions are minor (v 0.1) until they are made effective. Documents in an Effective state have major version numbers (v 1.0). Importing a File from your Computer 1. Select Import > File from the menu bar. 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. n 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

22 Create Documents Document Updates This section contains the following topics: Editing a Document, page 22 Checking in a Document, page 22 Editing a Document 1. Log in as a member of the Author group. 2. In the Document list, locate the document. 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. 4. Update, save, and close the document. Checking in a Document 1. In the Document list, locate the document. 2. Right-click the document and select Check in. The document is checked in and ready to add to a workflow. Related topic: Adding a Document to a Workflow, page 35 Configuring Content Templates When a user creates a document, the content for the new document is based on a content template. Depending on the document that the user creates, EMC Documentum Quality and Manufacturing automatically selects one or more appropriate content templates. Coordinators can create or modify content templates. The artifacts (document types) that Coordinators assign to a content template control the templates that appear to users when creating a document. Administrators can add new templates to EMC Documentum Quality and Manufacturing using standard D2 Config functionality described in the EMC Documentum D2 Administration Guide. EMC Documentum Quality and Manufacturing offers an alternative method of creating content templates in D2 Client. 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 22

23 Create Documents 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. Use D2 Client to perform these procedures. 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 Validation documents Change Request Topics in this section include: Modifying a Content Template, page 23 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 Validation Template.doc Change Request Template.doc 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 creating a document. 1. Log in as a member of one of the Coordinator groups. 2. In the Repository 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. 23

24 Create Documents 7. Click OK to update the content template properties. Configuring Dictionaries and Taxonomies Document 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 24

25 Create Documents 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 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. 25

26 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. 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 the value, 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

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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 topics: Change Requests, page 29 Change Requests Users create Change Requests to propose changes to documents or to request new documents. For example, a user can suggest corrections or improvements to documents. A Change Request is subject to review and approval before the document Author can implement the change. Change Requests can be stand-alone documents or attached to one or more documents. Change Requests have their own permissions, lifecycles, and workflow. Unlike other controlled documents, Change Requests do not require the initiator to be an Author because Authors (and Coordinators) have the ability to change documents and then submit them for approval. Typically, users initiate a Change Request because they want to improve a document. The user who creates the Change Request becomes the Change Request Author. Any additional authors assigned cannot change the other role members associated with the document. Related topics: Creating a Change Request, page 29 Attaching Additional Documents to a Change Request, page 31 Submit Change Request, page 80 Change Request Document Permissions, page 72 Creating a Change Request 1. Log in as a member of the Author group based on the type of document. 2. Select a controlled document in an Effective (Final), Release Pending, or Reviewed state that requires a change. The system creates a relationship between the Change Request and the selected document automatically to indicate that the document is subject to the proposed change. 29

30 Request and Track Document Changes Change Requests are not available for work-in-progress states such as Draft because users typically use Change Requests on documents that are about to be or already released. 3. Select New > Content from the menu bar. 4. In the Creation profile field, select Change Request. 5. In the GMP Categories field, select Change Request and then click Next. 6. In the Reason field, select the purpose of Change Request. 7. In the Description field, type a brief summary of the Change Request. 8. Select Revisions Required to request document modifications. Clear this check box for a new document or when there are no document modifications required. 9. Click Next. 10. If requested, select a location for the document on your local file system. 11. In the Change Request document in Microsoft Word, type the details of the proposed changes and then save and close the Change Request. 12. Click Check In and Finish. 13. To verify that the Change Request has your selected document attached: a. Select the Change Request and click Relations. b. Verify that document that you selected in step 2 appears. If the document does appear, verify that the document is in an Effective, Release Pending, or Reviewed state. 30

31 Request and Track Document Changes To attach additional documents, follow the Attaching Additional Documents to a Change Request, page 31 procedure. 14. After you have attached all relevant documents, right-click the Change Request and select Send to workflow > Submit Change Request. 15. In the Planning / Sending of Workflow dialog box, select the users to act as Change Managers, click Send, and then click OK. This sends the Change Request to the Submit Change Request workflow and changes the status to Submitted. Related topics: Attaching Additional Documents to a Change Request, page 31 Submit Change Request, page 80 Attaching Additional 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 and click Relations to view the current related documents. 2. In the Document list, right-click a document in an Effective, Release Pending, or Reviewed state and select Attach to Change Request. Change Requests are not available for work-in-progress states such as Draft because users typically use Change Requests on documents that are about to be or already released. 3. In the Attach document to Change Request dialog box, select a Change Request and click OK. 31

32 Request and Track Document Changes 4. Attach any other relevant documents to the Change Request. 5. Select the Change Request and click Relations to verify that the Change Request has the necessary documents attached. Related topic: Creating a Change Request, page 29 32

33 Review and Approve Documents Chapter 5 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 33 Document Review and Approval, page 35 Performing Tasks in a Workflow, page 36 Processing Documents in a Workflow, page 40 Working with Effective Documents, page 47 Viewing Document Status, page 48 Viewing Workflow Progress, page 48 Workflow Task Performer Changes, page 49 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 the specified reviewers to perform a review task. Each reviewer receives a review task. When a reviewer finishes a task, it goes to the next performer or finishes. 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 originate the document and start the workflow. Workflow supervisors are usually Authors or Document Coordinators. The Documentum Q&M solution provides three category levels to secure documents as the documents progress through the tasks of a workflow. The solution assigns the control categories internally based on the document type. These control categories are invisible to end users, but the control categories determine the workflows available for the documents. The following table describes the document control categories: 33

34 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 independent review and approval. Authors can act as Document Coordinators on Cat 3 documents. Documentum Q&M uses the following workflows for controlled documents: Workflow Collaborative Editing Submit for Review / Approval (Category 1) Submit for Review / Approval (Category 2) Submit directly for Approval (Category 2) 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 approve the document by accepting the task or annotate the document and send it back to the Author. 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. Document approvers must electronically sign off on the document. An Author cannot be an Approver on the same document. After all of the reviewing and approving tasks are complete, the document goes to the Document Coordinator. The Document Coordinator releases the document as an Effective version. Sends a document for review and approval. Some of the document approvals require electronic signatures. An Author cannot be an Approver on the same document. Category 2 documents do not require QO approval. Sends a document for approval without review. An Author cannot be an Approver on the same document. 34

35 Review and Approve Documents Workflow Submit for Review (Category 3) Description Sends a document for review. If you select multiple Reviewers, the workflow sends the documents to all of them at the same time. A Reviewer can approve the document by accepting the task or annotate the document and send it back to the Author. Submit to To Be Read (TBR) recipients (Category 1) 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. The following figure illustrates the typical order of the Documentum Q&M workflows: Document Review and Approval Adding a Document to a Workflow, page 35 Self-approving a Document, page 36 Adding a Document to a Workflow When you add a document to a workflow, Documentum Q&M provides workflow options based on the control category and the lifecycle state. 35

36 Review and Approve Documents 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 Change Requests: Change Request Author or Reader Unlike other controlled documents, Change Requests do not require the initiator to be an Author because Authors and Coordinators have the ability to change a document and then submit them for approval. The Change Request Author is a user who has access to the documents in an Effective, Release Pending, or Reviewed state and requests a change. 2. Right-click a document and select Send to workflow > (workflow name). 3. In the Planning / Sending of workflow dialog box: a. On the Recipients tab, verify the participant group fields. Modify the recipients as needed. 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. 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. Related topic: Chapter 9, Workflows Self-approving a Document Authors can self-approve control category 3 documents. 1. In the Document list, right-click a document and select Self-approve and make Effective. 2. Click OK. 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. EMC Documentum Quality and Manufacturing provides defined groups for each role. In the workflows for controlled documents and Change Requests, task participants have five days to perform a task. Tasks participants receive messages in their Tasks inbox to remind them that a task requires attention. Administrators can modify the default settings in D2 Config. The EMC 36

37 Review and Approve Documents Documentum D2 Administration Guide provides configuration information. By default, 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. When there are 0 days left, a final message is sent to the task participants informing the workflow initiator that the task will be rejected. The following actions are standard workflow actions for processing tasks in EMC Documentum D2: 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. Reject Task: Confirms that the task is completed or its quality was not acceptable. Abort workflow: Closes the workflow. Administrators and the supervisor of a workflow can perform this task. The EMC Documentum D2 User Guide provides additional information on performing standard Documentum D2 tasks in a workflow. Related topics: User Roles, page 62 Viewing the Audit Trail, page 37 Categorizing Inbox Tasks, page 38 Viewing the Audit Trail EMC Documentum Quality and Manufacturing audits events for controlled documents and change request documents. The system does not audit events for non-controlled documents. 1. Click the Tasks button 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 report information in a read-only, portable format, right-click the Audit tab and select Export to Excel. 37

38 Review and Approve Documents Categorizing Inbox Tasks Follow this procedure to categorize inbox tasks. 1. Click the Tasks button. 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. 38

39 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 see the tasks in Workflow tasks list tab. 39

40 Review and Approve Documents Processing Documents in a Workflow The following topics describe how to process documents in a workflow: Document Editing, page 40 Editing a Document in a Workflow, page 40 Incorporating Document Changes, page 41 Reviewing Documents in a Review Task, page 41 Reviewing Document Feedback from Reviewers, page 43 Reviewing and Approving Change Request Documents, page 43 Reviewing Authorized Change Request Documents, page 44 Approving Documents, page 44 Releasing Control Category 1 Documents as Effective Versions, page 45 Document Editing In the Collaborative Editing workflow, Authors and Reviewers edit documents in the Edit document task. The Author originating the document incorporates the changes into the document from the Reviewer feedback. When the Collaborative Editing workflow finishes, add the document to a review and approval workflow. In the Submit Change Request workflow: Authors edit the documents related to the Change Requests in the Enact Change Request task. Coordinators edit the Change Requests in the Review and Revise Rejected CR task. Follow these procedures to edit documents: Editing a Document in a Workflow, page 40 Incorporating Document Changes, page 41 Editing a Document in a Workflow 1. Depending on the workflow, log in as a member of an Author, Reviewer, or Change Request Coordinator group. 2. In the Workflow task list, select the task. 3. In Task Attachment, select the document and then select Content > Native annotations from the menu bar. 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 Microsoft Excel, Microsoft PowerPoint, and so on. See the EMC Documentum D2 User Guide for more information about annotations. 40

41 Review and Approve Documents 4. Edit the document in its native format and save the changes. The EMC Documentum D2 Administration Guide provides information on configuring Microsoft Office products to show Documentum D2 properties. 5. Click Relations, right-click the document with annotations, and select Check in. 6. In the Workflow task list, right-click the task, select Accept task, add a comment, and click OK. When the task is accepted, the document routes to Authors in the Incorporate changes task. Incorporating 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. 4. In Task Attachment, select the document and then select Content > Edit with native annotations 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 Accept task. 8. In the Task dialog box, select one of the options: Select Finish the editing workflow to complete the task. 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, and click OK. If this option is not available, the document must be formally-reviewed and approved before it becomes Effective. Reviewing Documents in a Review Task In the Review tasks of the controlled document workflows, Reviewers review documents. The Author that originates the document 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, double-click the document and annotate the PDF. 41

42 Review and Approve Documents 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 > Native annotations from the menu bar. b. Edit the document in its native format and save the changes. The EMC Documentum D2 Administration Guide provides information on configuring Microsoft Office products to show Documentum D2 properties. 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: a. After reviewing the document, in the Workflow task list, right-click the task and select Accept task or Reject task to demote the document to a Draft task for additional review by an Author. 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. c. For Change Request documents, add a comment and click OK. The task is accepted and proceeds to the next task. 8. For Control Category 3 documents: a. After reviewing the document, in the Workflow task list, right-click the task and select Accept task. b. Select one of the following options: Change to Reviewed: This option approves the document and it proceeds to the Ready to be Made Effective task. Change to Draft: This option rejects the document and returns it to the Author as a Draft task. c. Add a comment and click OK. The document proceeds to the next task. 42

43 Review and Approve Documents Reviewing Document Feedback from Reviewers When the Reviewers return a document to the Author (document 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. 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 > Edit with native annotations 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. Right-click the task and select one of the following options to complete the task: Select Accept task to route the document back to the Approver or Reviewer. Select Reject task to complete the workflow. You can add the document to another workflow, such as the Collaborative editing workflow for additional editing. Reviewing and Approving Change Request Documents The Submit Change Request workflow contains additional reviewing and approving tasks: Review Change Request Task: The Change Manager accepts the task and reviews the Change Request to decide on the workflow participants and the course of action. Task tab: Self-approve minor change for implementation by the Document Authors: The task proceeds to the Document Author for implementation. Send for further review by the Authors prior to approval / implementation: The task proceeds to the Authors for initial review, then to the Approvers, and then back to the Authors for implementation when the Change Request is approved. Send for approval only, then directly to the Authors for implementation: The task proceeds to the Approvers, and then to the Authors for implementation when the Change Request is approved. Workflow particpant(s) tab: Change Managers: Coordinate the review, approval, and implementation of the Change Request. In the subsequent review and approval steps, the system updates the Process Info 43

44 Review and Approve Documents tab of the attached documents with the selected Change Manager so they have access to the attached document. Change Approvers: Approve significant changes. Minor changes can be approved by the Change Managers. Document Authors: Implement the document changes. Implement Approved Change Task: On the Relations tab, Authors access the documents attached to the Change Request and make the necessary changes. Documents can be sent for independent review and approval as needed. Confirm completion Task: Verify CRQ completed: Change Request Managers or Authors review the changes to the related documents and ensure the required changes are complete. They accept the task to complete the workflow or reject it and return to the Change Request Manager. If this is a stand-alone Change Request (without any attachments), they mark it as Completed using the Content menu option. Otherwise, the system marks it as Completed automatically when users revise the documents and the documents become Effective. After the approval of a Change Request, you cannot remove the attachment documents. Reviewing Authorized Change Request Documents Change Request documents have an additional Review task for implementing an authorized Change Request. This task allows Authors to review the attachments in the Relations tab. 1. Log in as an Author. 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. Click Relations to review the attached documents: Edit documents as needed. Check in new documents. Send documents for independent review and approval if necessary. Detach documents that are no longer needed. 6. To attach another document to the Change Request, right-click the document and select Attach to Change Request. 7. Select Accept task to route the Change Request to the Change Coordinators for final confirmation. Approving Documents In the Approval tasks, Control Categories 1 and 2 documents require approval from the Approval and Quality Organization (QO) Approval groups. Change Requests require approvals from Approval groups. If the documents require a signature, all of the specified Approvers must sign off on the document. 44

45 Review and Approve Documents 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 task. 6. To approve the document, right-click the task and select Accept task. Control Category 1 and 2: The Sign off dialog box appears for all of the Control Categories 1 and 2 documents. Change Requests: 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 of the attached documents. Signing off on each attached document is not required. When completely approved, it forwards automatically to the Author for implementation. a. For Control Category 1 and 2 documents, 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, type a comment and click OK. The task is accepted and proceeds to the next task. Releasing Control Category 1 Documents as Effective Versions Document Coordinators release Control Category 1 documents to an Effective state after all of the reviewing and approving 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. 45

46 Review and Approve Documents 5. Select one of the following options: Set dates and Finish (Leaves the document in the current state): Use this option for documents with delayed Effective dates. The document remains in a Release Pending state until the Document Coordinators locate the document to make it Effective. Alternatively, if the Effective date for the document is in the future, the system sends the Document Coordinators an . The is sent the day before the document is scheduled to be made Effective and reminds the Document Coordinator to make the document Effective. To make the document Effective, the Document Coordinator selects Make Effective or Cancel document release and revert to Draft. Set dates and send for review (Sends the document to To Be Read users): Use this to send documents to the TBR Distribution List for recipients to read the document. The document remains in a Release Pending state. After all of 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. Set dates and promote (Makes the document effective): 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 Make Effective automatically Effective from date To expiry date Review Date Description Select to automatically promote the document to Effective on the specified Effective date of the document. This option is also available for Control Category 1 documents using the Adjust Effective / Review / Expiry Dates menu option. Select the date when the document becomes Effective with a major version number. The document remains Effective unless it Expires or is Suspended, Withdrawn, or Superseded by a later Effective version. Set an optional expiration date for the document. Set an optional review date for the document. 8. On the Set recipients and readers tab, specify the users who can read the document once 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 Submit to To Be Read recipients workflow tracks users to ensure that they have read the document. Select the users to notify after the document becomes Effective. They can read the document while it is Effective. 46

47 Review and Approve Documents 9. Click OK. The document progresses based on the options selected in the previous steps. Working with Effective Documents This section contains the following topics: Suspending a Document, page 47 Withdrawing a Document, page 47 Superseded Documents, page 47 Suspending a Document Suspending an Effective 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. 1. In the Document list, right-click a document in the Effective state and select Suspend document. 2. Click OK. 3. To reinstate the document, select Reinstate as Effective version. Withdrawing a Document You can retire documents in the Draft, Release Pending, or Effective 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. In the Document list, right-click a document and select Withdraw document. 2. Click OK. 3. To reinstate a withdrawn document, select Revert to Draft. Superseded Documents Superseded documents are documents that were previously Effective. There is only one Effective version of a document at a time. The system automatically updates the document state when new Effective versions are created. For example: 1. Version 0.1: Process a document in a Review / Approval workflow. 2. Version 1.0: Document Coordinators change the document state to Effective. The version is Version 1.1: The document is edited and in a Draft state. 47

48 Review and Approve Documents 4. Version 1.1: Process a document in a Review / Approval workflow. 5. Version 2.0: Document Coordinators change the document state to Effective. The updated Effective document is version 2.0. The original document, which was version 1.0, is now automatically changed to Superseded. Viewing Document Status Users can view the progress of a document in the document properties. 1. In the Document 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. 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 Document list and click Workflow overview. 3. Expand the workflow to view the workflow tasks. Active workflows and tasks show a Running state. 48

49 Review and Approve Documents 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. 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. 49

50 Review and Approve Documents Updating Workflow Task Performers 1. Log in as a workflow supervisor. 2. Navigate to the document for which you are updating performers. 3. In the Document 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. Performers of all current activities as well as future activities can be modified other than Document Coordinator. Document Coordinator can be updated only for the future activities. 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 Document 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 Document 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, expand the workflow, right-click the user whose task you want to delegate, and select Delegate task. 50

51 Review and Approve Documents 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. 2. Right-click a document and select Reassign Roles. Change the user groups assigned to the roles as needed. Each tab represents a different user role. For example, on the Approvers tab, you can replace the Approvers listed for that role. 3. Click OK. 51

52 Review and Approve Documents 52

53 Working with Documents Chapter 6 This section is those who audit quality and manufacturing documents. This section contains the following topics: Locating Documents, page 53 Finding Documents using a Public Search, page 53 Viewing Documents and their Properties, page 54 Viewing the Document History, page 54 Exporting the Document List to Microsoft Excel, page 54 Find Documents, page 55 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 Document 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 Search tab. 3. In the Searches > Public Searches folder, double-click a search query, such as the Find Effective / Final Documents search query. 4. Complete the required search fields and click Run. 53

54 Working with Documents Viewing Documents and their Properties 1. To view the document without downloading it to your computer, select a document in the Document 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 (Final) 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. Exporting the Document List to Microsoft Excel You can export the list of files in the Document list to a Microsoft Excel spreadsheet. 1. Right-click the Document list tab and select Export to Excel. 2. Select a location for the file on your local file system. 54

55 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 / Final Documents Find Effective / Final 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 for a User Show Current Workflow Progress 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 lifecycle state based on a specified product and an optional therapeutic area and keyword. Finds documents in an Effective 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 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. Shows a list of workflow tasks for all running workflows for the selected document. 55

56 Working with Documents 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. 56

57 Chapter 7 Print and Export Documents In Documentum Q&M, the Controlled Print and Export feature is available for Control Category 1 documents. Use standard Documentum D2 functionality to print other types of documents. EMC Documentum Quality and Manufacturing prints and exports a PDF rendition of the original document. For example, if you export a Microsoft Word document, the result is a PDF rendition. This section contains the following topics: Printing a Control Category 1 Document, page 57 Exporting Control Category 1 Documents, page 58 Printing a Control Category 1 Document In Documentum Q&M, the requirements for controlled printing are: The PDF rendition capability is enabled in the environment. The client machine must have an application to read PDF documents. Users must be a member of the Document Coordinator group. The documents to be printed must be Control Category 1 documents in an Effective (Final) state. 1. Log in as a member of the Document Coordinator group. 2. Select the document and then select Content > Print through C2 > Controlled Print from the menu bar. 3. In the Print dialog box, type the name of the person requesting the print, the reason for printing, and click OK. The PDF viewer application displays the cover sheet and read only printing details, such as the name of the person printing a document and the reason for printing the document. The document prints a PDF rendition with a print date. Users can include a watermark of a document validity statement such as Valid for 7 days from print date. If the document that was printed is no longer Effective (Final), a workflow process starts to recall the document. 57

58 Print and Export Documents Related topics: Cross-functional User Groups, page 64 Recall Document (Category 1), page 79 Exporting Control Category 1 Documents In D2 Client, the requirements for exporting documents with the Controlled Export feature are: The PDF rendition capability is enabled in the environment. The client machine must have an application to read PDF documents. Users must have access to the document and the data displayed on the cover sheet. The document must be in an Effective (Final) state. 1. Log in as a user with access to the document and the data that is played on the cover page. 2. Select the document and then select Content > Export through C2 > Controlled Export from the menu bar. The PDF viewer application displays the cover sheet and read only printing details, such as the name of the person printing a document and the reason for printing the document. The document prints a PDF rendition with a watermark that states that the document is invalid after the specified Effective (Final) date. If the document that was printed is no longer Effective (Final), a workflow process starts to recall the document. Related topic: Recall Document (Category 1), page 79 58

59 Chapter 8 Document Control EMC Documentum Quality and Manufacturing uses control categories in association with lifecycles, user roles, and permissions to control access to the various documents. This section contains the following topics: Control Categories, page 59 Change Request Control, page 62 User Roles, page 62 Document Lifecycle Models, page 64 Permissions, page 71 Control Categories The Life Sciences solution provides three lifecycle control categories to secure documents as the documents progress through the tasks of a workflow. The control categories are assigned internally by the solution based on the document type. These control categories are invisible to end users. The control categories and associated user roles and lifecycle states control which users can access each document. Control Categories 1 3 documents proceed through defined controlled lifecycles. The common security features for all control categories: Allow joint and collaborative authoring in Documentum D2. Restrict access to content based on user role and lifecycle state. Allow complete withdrawal of the document with optional retention of historic copies. The following table describes the security of the document control categories: 59

60 Document Control Control Categories Category 1 Security Description Controlled documents that require formal review and approval along with signoff by the Quality Organization (QO). These documents become Effective and may be sent on TBR and periodic review workflows. The workflow process includes: Independent two person review and approval before release. Approval with electronic signatures for specific document types. Additional approval by the Quality Organization department before release. Controlled release by Document Coordinators. Controlled release that can be deferred until a specified effective date. Effective versions that automatically rescind on expiration. Effective versions that can be suspended and reinstated on demand. Effective versions that can be superseded when the next version becomes effective. Category 2 Expiration notifications. Controlled documents that require formal review and approval. They do not require signoff by the Quality Organization. The workflow process includes: Independent two person review and approval before release. Approval with electronic signatures for specific document types. Documents that become effective immediately. Effective versions that can be suspended and reinstated on demand. 60

61 Document Control Control Categories Category 3 Security Description Effective versions that can be superseded when the next version becomes effective. Controlled documents that can be self-approved by Authors. Independent review and approval is not required. This category is typically assigned to documents that are created and/or approved outside of the system. The workflow process: Enables self-approval by Authors. Makes the previously Effective version superseded when the next version becomes Final. Allows the Effective version to be suspended and reinstated on demand. The following table shows the user roles and document lifecycle states associated with the document control categories: Control Categories User Roles Lifecycle States Category 1 Category 2 Category 3 Approvers Auditors Authors Document Coordinators Quality Organization (QO) Approvers Readers Reviewers Approvers Auditors Authors Readers Reviewers Auditors Authors Readers Regulatory Affairs Reviewers Draft For Review For Approval Release Pending Effective Suspended Expired Superseded Withdrawn Draft For Review For Approval Effective Suspended Superseded Withdrawn Draft For Review Reviewed Effective Suspended Superseded Withdrawn 61

62 Document Control Change Request Control Users can also create comments and Change Requests (CRs). Comments and Change Requests can be in any category and related to any document. The security features include the features common to all of the documents and enable self-approval and release by Authors. The following roles participate in the Change Request workflow: Auditor Authors Approvers Document Coordinators Reviewers Change Request documents use the following lifecycle states: Draft For Review For Approval Approved Completed Rejected Related topic: Change Requests, page 29 User Roles EMC Documentum Quality and Manufacturing provides defined user roles that enable or restrict user access to documents and information in the system. The following table describes the user roles: User Role Groups Description Administrators cd_admingroup Access administrative functions but do not have access to controlled documents. Approvers cd_<applicable site>_approvers Approve controlled documents (Control Category 1 and 2). Some documents require electronic signatures. Auditors cd_<applicable site>_auditors Have read-only access to audit logs, Effective, Superseded, and Expired documents. They can view document content, history, and properties. They must have a minimum extended privilege of View Audit. 62

63 Document Control User Role Groups Description Authors cd_<applicable site>_authors Create documents and submit them for collaborative editing, review, and approval. Control Categories 1 and 2: Authors cannot be an Approver. Document Coordinators cd_<applicable site>_coordinators Control Category 3: Authors can approve documents and act as Document Coordinators. Manage the release of controlled documents. Control Category 1: Schedules release dates. Verifies that all members of the To Be Read (TBR) Distribution List have signed off on a document or rejected the task in the Submit to To Be Read recipients workflow before the document becomes Effective. Control Categories 1 and 2: Releases documents to an Effective state and controls the long-term management of the document. Can submit a document to a workflow. Quality Organization Approvers cd_<applicable site>_qo _approvers Control Category 3: Authors can act as Document Coordinators. Responsible for final approval of Control Category 1 documents. Readers cd_<applicable site>_readers General consumers with read-only access to Effective versions. (Optional) Recipients on the To be Read (TBR) Distribution List receive notification when a Control Category 1 document is scheduled to become Effective. They confirm that they have read the document. When a Reader requests a printable PDF, the system adds them to the TBR Distribution List. Typically, PDFs are secure and do not allow local printing, editing, or annotation. Reviewers cd_<applicable site>_reviewers Review documents using annotations and edit documents. They are responsible for technical review during the authoring and review cycle. 63

64 Document Control EMC Documentum Quality and Manufacturing includes these defined user groups: Cross-functional User Groups, page 64 Cross-functional User Groups The following table describes the cross-functional user groups: Groups cd_admingroup Description Administrator: Access to administrative functions Require Administrative client capability Do not have access to controlled documents Document Lifecycle Models This section describes the state transitions for the control category documents. This section contains the following topics: Control Category 1 Documents Lifecycle, page 65 Control Category 2 Documents Lifecycle, page 66 Control Category 3 Documents Lifecycle, page 67 Control Categories 1 3, page 68 Additional Menu Functions, page 70 64

65 Document Control Control Category 1 Documents Lifecycle The following figure illustrates the lifecycle state transitions in the Control Category 1 Documents Lifecycle Model: 65

66 Document Control Control Category 2 Documents Lifecycle The following figure illustrates the lifecycle state transitions in the Control Category 2 Documents Lifecycle Model: 66

67 Document Control Control Category 3 Documents Lifecycle The following figure illustrates the lifecycle state transitions in the Control Category 3 Documents Lifecycle Model: 67

68 Document Control Control Categories 1 3 The following table describes the document states and the applicable control categories: State Control Category Description Draft 1, 2, 3 Indicates new documents and versions added and prepared by Authors. For Review 1, 2, 3 Indicates documents submitted for review by Reviewers. Reviewed 3 Indicates that the review phase is completed. For Approval 1, 2 Indicates documents submitted for sign-off by Approvers. Release Pending 1, 2 Indicates documents that have been signed-off by all designated Approvers. Document Coordinators make the document Effective. Effective 1,2, 3 Indicates documents that are approved for use and current. Indicated by a major version number. Readers can view the Effective version of documents. Suspended 1, 2, 3 Indicates an Effective or Final document that was changed to Suspended by a Document Coordinator. This state prevents the document from being used while a modified version is being prepared, reviewed, and approved. Suspended documents can be reinstated to Effective if necessary, or changed to Superseded when the next version or replacement document becomes Effective. Alternatively, the entire document can be Withdrawn. Superseded 1, 2, 3 Indicates a previously-effective version of a document that was replaced by a more recent version that was Reviewed, Approved, and made Effective. All Superseded version are retained by the system. 68

69 Document Control State Control Category Description Expired 1 Indicates a document that was previously Effective but is now past its expiration date. Before they expire, the documents are reviewed and expiration date is rescheduled or revised to generate a new version. Withdrawn 1, 2, 3 Indicates retired documents. All versions are withdrawn together. Cannot be versioned, but can be copied to create a document. Document Coordinators can withdraw a document at any time, which affects all versions. Users are not allowed to create new versions of a Withdrawn document. However, it can be reverted to Draft if necessary, to enable its content to be reused, or deleted. Retain Withdrawn documents as historical records. 69

70 Document Control 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 Attach to Change Request* Reassign roles 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 the selected document to be linked to a Change Request. The Change Request must currently be in the Draft or Rejected state, and the user must be an Author of that Change Request (for example, the user who created it). For the selected document to attach to a Change Request, it must be in the Release Pending, Reviewed, or Effective lifecycle state. If you preselect a document in one of these states when creating the Change Request, the document automatically attaches to the new Change Request. However, you can link other documents to the same Change Request using this function. Enables users to adjust the current role settings for all future performers. For Control Category 1 and 2 documents, the user must be a Document Coordinator in order to use this function. For Control Category 3 documents, the user must be either a Document Coordinator or an Author. In all cases, the system audits role changes. Adjust Effective / Review / Expiry dates If a document is with an Approver, users cannot reassign roles to Quality Organization (QO) Approvers. Users cannot reassign roles in a To Be Read (TBR) recipients workflow. Enables users to modify the effective date, review date, and expiry date settings for the selected document. For Control Category 1 and 2 documents, the user must be a Document Coordinator in order to use this function. For Control Category 3 documents, the user must be either a Document Coordinator or an Author. *Any user can create a Change Request. A Change Request contains a request to change to an existing document or to create new documents, which is subject to review and approval. 70

71 Document Control Permissions EMC Documentum Quality and Manufacturing configures the permissions of document based on the user role and the document category. Permissions are defined for each item in the repository. Permissions identify the security level needed for a group or user to access the item and their allowed actions. The basic permissions in Documentum D2 are: NONE: Cannot access any object or object attributes. BROWSE: Can view the properties of the object. READ: Can view the properties of the object and content. RELATE: Same as READ, plus users can add object annotations. VERSION: Same as RELATE, plus users can change object content. WRITE: Same as VERSION, plus users can alter attributes and change content without updating the version. DELETE: Same as WRITE, plus users can delete any object. The EMC Documentum D2 User Guide provides additional information on permissions. The following topics describe the permissions by control category that are available in EMC Documentum Quality and Manufacturing: Control Categories 1-3 Document Permissions, page 71 Change Request Document Permissions, page 72 Control Categories 1-3 Document Permissions The Documentum Q&M permissions for Control Categories 1 3 documents are listed in the following table for the authors, document coordinators, reviewers, and approvers roles: State Authors Document Coordinators Reviewers Approvers (Cat 1 2 only) QO Approvers (Cat 1 only) Draft DELETE WRITE WRITE NONE NONE For Review (Cat 1 and 2 only) Reviewed (Cat 3 only) For Approval (Cat 1 and 2 only) Release Pending (Cat 1 and 2 only) RELATE RELATE RELATE NONE NONE VERSION READ READ NONE NONE READ READ READ READ READ VERSION READ READ READ READ Effective (Final) VERSION READ READ READ READ 71

72 Document Control State Authors Document Coordinators Expired (Cat 1 only) Reviewers Approvers (Cat 1 2 only) QO Approvers (Cat 1 only) VERSION READ READ READ READ Superseded VERSION READ READ READ READ Suspended VERSION READ READ READ READ Withdrawn READ READ READ READ READ The Documentum Q&M permissions for Control Categories 1 3 documents are listed in the following table for the recipients, readers, and auditors roles: State Recipients TBR List (Cat 1 only) Readers Auditors Regulatory Affairs Draft NONE NONE NONE RELATE For Review (Cat 1 and 2 only) Reviewed (Cat 3 only) For Approval (Cat 1 and 2 only) Release Pending (Cat 1 and 2 only) NONE NONE NONE RELATE NONE NONE NONE READ NONE NONE NONE READ READ NONE READ READ Effective (Final) READ READ READ READ Expired (Cat 1 only) BROWSE NONE READ READ Superseded BROWSE NONE READ READ Suspended BROWSE NONE READ READ Withdrawn BROWSE NONE NONE READ Change Request Document Permissions The Documentum Q&M permissions for Change Requests (CRs) are: State CR Authors CR Document Coordinators CR Reviewers CR Readers CR Approvers Auditors Regulatory Affairs Draft DELETE NONE NONE NONE NONE NONE NONE Submitted READ WRITE NONE NONE NONE NONE NONE For Review READ READ RELATE NONE NONE NONE NONE 72

73 Document Control State For Approval CR Authors CR Document Coordinators CR Reviewers CR Readers CR Approvers Auditors Regulatory Affairs READ READ READ READ NONE NONE NONE Approved READ READ READ READ READ READ READ Completed READ READ READ READ READ READ READ Rejected DELETE READ READ READ NONE NONE READ Related topic: Permissions, page 71 73

74 Document Control 74

75 Workflows Chapter 9 EMC Documentum Quality and Manufacturing provides generic workflows to process Control Category 1 3 documents and Change Requests. Workflows are composed of tasks that provide business logic to the lifecycle phases and pass content from one state to another. This section contains the following topics: For Collaborative Editing (Categories 1-3), page 75 Submit for Review / Approval (Category 1), page 76 Submit for Review / Approval (Category 2), page 77 Submit Directly for Approval (Category 2), page 77 Submit for Review (Category 3), page 78 Submit to To Be Read recipients (Category 1), page 78 Recall Document (Category 1), page 79 Submit Change Request, page 80 For Collaborative Editing (Categories 1-3) Use this workflow to send a Control Category 1-3 document for collaborative editing before sending it to one of the review and approval workflows. The system automatically performs the tasks with the icon. Users with specific roles perform the tasks with the icon. Users perform the tasks described in the following table: 75

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