PharmaReady Version 5.1 SPL Workflow Operational Qualification Complete Installation Software Release Date 28 Jan 2013

Transcription

1 PharmaReady Version 5.1 SPL Workflow al Qualification Complete Installation Software Release Date 28 Jan 2013 Doc Version 1.0 Jan 28, 2013 Company Name: Address: Project Name: Server Name: Server Location: OQ Prepared By: Name / Title / Representing Signature / Date

2 TABLE OF CONTENTS 1. Objective Procedure Prerequisites Execution Protocol Completion Acceptance Criteria Document Control Revision History Pre-OQ Approval from Customer: OQ Roles and Responsibilities: Execution/Review Signature Verification SPL Logon Qualification SPL Create SPL Qualification A. Author ESTABLISHMENT REGISTRATION Qualification SPL Drug Listing Data & Narrative content Qualification SPL Approve Label Qualification SPL Publish Label Qualification Post OQ- Approval FROM CUSTOMER Appendix I SPL Example Zip File Protocol Deviation Report Release Date 28 Jan 2013 Page 2 of 40

3 1. OBJECTIVE This protocol outlines the requirements for the al Qualification (OQ) of the SPL workflow functions of PharmaReady version 5.1 by TAKE Solutions. The OQ protocol defines the data required to characterize the software and the field verifications that confirm the software provides the basic operational capabilities related to the document workflow functions as defined by the manufacturer. Successful completion of this protocol will provide assurance that the software is installed in accordance with applicable manufacturer s recommendations, and establishes a baseline of test workflow data for use in change control and to aid in troubleshooting. This protocol is a part of the overall validation effort for PharmaReady version 5.1. IQ s and/or OQ s may be developed by the customer and executed in lieu of or in conjunction with the manufacturer s documents. 2. PROCEDURE 2.1. Prerequisites 2.2. Execution All hardware, software, and infrastructure requirements must be completed. All Installation Qualifications protocols have successfully passed execution. The SPL Admin al Qualification has successfully passed execution. Data within the OQ will be used as written for the first execution of this OQ. In order to ensure uniqueness for any subsequent executions of this OQ, a letter will be prepended to all data values starting with A for the second execution, B for the third, etc. Print the al Qualification document. Execute the al Qualification on the PharmaReady client machine. Follow the instructions for each table in this document. Document all results, reviews, verifications, and screen shots at the time they are executed. All screen prints must be created in a single MS Word document entitled SPL Screen Capture Document. The SPL Screen Capture Document will be labeled with the following information: o Header contains: Project Name: Version#: Test Case Name: SPL o Each Picture in Screen Capture Document Test Case Step # above or below picture o Each Page of Screen Capture Document Testers Initials Testing Date Assemble SPL Screen Capture Document to the back of the applicable test case. Tester The Tester writes their name in the Performed by field at the beginning of each section. The Tester enters Pass or Fail in the Observed Results As Expected column. If the expected results are not as expected write a deviation report. The tester should write a deviation report when: o The protocol step is inaccurate. o The data is entered incorrectly. Release Date 28 Jan 2013 Page 3 of 40

4 o A screen shot was not taken for a required step. The Tester enters their initials and the date in the column to indicate an acceptable result. The Tester will label each screen print with the section identified, corresponding to results. Verifier The Verifier verifies the execution of the OQ and ensures all screen captures reflect the correct data. The Verifier reviews the documentation to ensure all sections are completed. The Verifier writes their name in the by field at the beginning of each section. Reviewer The Customer QA/Regulatory representative will review the documentation to ensure all sections are completed and writes their name in the Reviewed by field at the end of each section. The Reviewer reviews the documentation to ensure all sections are completed Protocol Completion After completing the execution of the OQ, TAKE Solutions will retain a photocopy of the completed OQ document and all supporting documentation for support purposes. TAKE Solutions will provide original executed OQ documents to the customer. After completing the execution of the al Qualification, submit the completed protocol with supporting data and all deviation reports to the Quality Assurance Director / Manager. A Validation Summary Report is prepared after execution of all applicable OQ protocols, summarizing the results. The customer will retain the completed original documents and all supporting documentation and TAKE Solutions will retain a photocopy of the original documents for future product support Acceptance Criteria Criteria for accepting the al Qualification SPL Admin phase as being complete are: o The OQ document has been executed and all screen captures are printed, labeled, initialed, and dated. o Any deviations encountered have a corresponding deviation report that is corrected or resolved. o The OQ document has been verified by a witness. o The OQ document has been reviewed by quality assurance or designee. o The OQ document has been approved by the customer. Approver The Customer QA/Regulatory/Project Manager will approve the documentation to ensure all sections are completed and write their name in the Post-Execution Approval table at the end of the protocol. Approval of the executed SPL Admin OQ indicates that the criteria outlined in this protocol have been met and indicates acceptance of the system. Release Date 28 Jan 2013 Page 4 of 40

5 3. DOCUMENT CONTROL Authored by: Reviewed by: Approved by: Ashok John, Implementation Engineer Date 24 Jan 13 Hari Priya, Analyst Quality Date 25 Jan 13 Vijay Srinivasan, Sr. Manager Implementation & Support Date 28 Jan REVISION HISTORY Version Date Author Remarks Jan 13 Ashok John Finalized the OQ as per the 5.1 changes 5. PRE-OQ APPROVAL FROM CUSTOMER: The signatures below indicate approval of this OQ for execution by authorized customer staff. Name/Title Signature Date Release Date 28 Jan 2013 Page 5 of 40

6 6. OQ ROLES AND RESPONSIBILITIES: Indicate each person s responsibility in the operational qualification protocol process. Name Title Role (Tester, Verifier, Reviewer, Approver) 7. EXECUTION/REVIEW SIGNATURE VERIFICATION Instructions: All personnel (customer and TAKE Solutions) assigned to execute, verify or review this protocol must sign and initial in the space provided below. This is for signature and initial verification. Printed Name Signature and Initials Affiliation Release Date 28 Jan 2013 Page 6 of 40

7 8. SPL LOGON QUALIFICATION Instructions: Qualify the basic operational features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: 8.1. Logon to PharmaReady using the SPL Admin account with these credentials: Logon ID: OQSPLAdmin Password: password The My Preferences page displays with the following message: Your password has expired. Please enter a new password On the My Preferences page, enter a new password for the test SPL Admin account by entering the following fields. Current Password: password New Password: password1 Confirm New Password: password1 Click the Submit button. The User is forced to change the password using the My Preferences page. The new password is submitted and the PharmaReady Home page displays. Comments: Section Reviewed By: Date: Release Date 28 Jan 2013 Page 7 of 40

8 9. SPL CREATE SPL QUALIFICATION Instructions: Qualify the basic operational features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: 9.1. From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select Create SPL sub menu item. The Add New SPL page displays Define a new label by entering the following data in the associated fields. Document Type: Establishment Information Sponsor: [read only] Program: [read only] Product Name:[read only] SPL Filename: OQ Establishment Internal Version #: 1.0 FDA Version #: 1 Schema Version: [read only] Stylesheet Version: [read only] Description: Sample Description The Add New SPL page displays with the newly added Label Information fields completed. Release Date 28 Jan 2013 Page 8 of 40

9 9.3. Define a new Label by entering the following data in the Rights section. Label Owners: Test, SPLAdmin Label Editors: Test, SPLAuthor Publishers: Test, SPLPublisher Label Submitters: Test, SPLSubmitter Readers: Test, SPLReviewer The Add New SPL page displays with the newly defined Rights fields completed Define part of a new SPL by setting the following options in the Key Dates fields (select date using Calendar icon): Author Start Date: Today s date Author Stop Date: Today s date Publish Date: Today s date Submit Date: Today s date Effective Start Date: Today s date Effective Stop Date: Today s date + 5 days E-Signature Information Meaning: Created new label Logon ID: Prepopulated with OQSPLAdmin Password: password1 Comments: blank Click the Submit button. The Header information page of the created SPL appears. Release Date 28 Jan 2013 Page 9 of 40

10 Comments: Section Reviewed By: Date: Release Date 28 Jan 2013 Page 10 of 40

11 10.A. AUTHOR ESTABLISHMENT REGISTRATION QUALIFICATION Instructions: Qualify the basic operation of administrative features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: Log off the active account and logon to PharmaReady using the SPL Author account with these credentials: Logon ID: OQSPLAuthor Password: password The My Preferences page displays with the following message: Your password has expired. Please enter a new password On the My Preferences page, enter a new password for the SPL Author account by entering the following fields. Current Password: password New Password: password1 Confirm New Password: password1 Click the Submit button. The User is forced to change the password using the My Preferences page and, when the new password is submitted, the PharmaReady Home page displays From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select the Work with Labels sub menu item. In the Document type drop down Select Establishment Registration Click the > symbol next to OQ Establishment to expand the listing and then click the icon under the Authoring column. The Header Information page displays. Release Date 28 Jan 2013 Page 11 of 40

12 10.4 In the Header information page, enter the following details. Registrant Tab: Effective Time: Current date [select using the calendar icon] Company Name*: OQ Company[chose from dropdown, which is added in Regulatory Identifiers page ] DUNS*: [displays the appropriate value for the company selected] Contact Information: Contact Person: Deborah Tyler Address: 222, Bonifant Avenue City: Pennsylvania Country: USA State: Washington Zip: deborahtyler@acme.com Telephone: Click Save button. All the Registrant details entered are saved and message appears as Registrant Information saved successfully, 10.5 Click on Add Establishments button in the Header information page. Establishment s page appears. Release Date 28 Jan 2013 Page 12 of 40

13 10.6 Enter the following information for adding an Establishment. Establishment: OQ Company[select from dropdown] DUNS: FEI: Address: 777, Sampson Street, Country: United States State: Pennysylvania City: Mason Zip: Business Info: Select Manufacture from the Available list box to assigned list box using > add button. Contact Party Info: Contact Person: Pam Jamison Address: 777, Sampson Street City: Mason State: Pennysylvania Country: United States Zip: : pam.jamison@acme.com Telephone: Click Save button. The Header information page appears and verify the added establishment [OQ Company] appears in Establishments List section grid Click on Preview icon. A new browser window displays the Establishment Registrant information. Release Date 28 Jan 2013 Page 13 of 40

14 10. B. CREATE NDC LABELER CODE REQUEST Instructions: Qualify the basic operation of administrative features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: 10.1 Logon to PharmaReady using the SPL Admin account with these credentials: Logon ID: OQSPLAdmin Password: password1 The PharmaReady Homepage Displays From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select Create SPL sub menu item The Add New SPL page displays Define a new label by entering the following data in the associated fields. Document Type: NDC Labeler Code Request Sponsor: [read only] Program: [read only] Product Name:[read only] SPL Filename: OQ NDC Internal Version #: 1.0 FDA Version #: 1 Schema Version: [read only] Style sheet Version: [read only] Description: Sample Description The Add New SPL page displays with the newly added Label Information fields completed. Release Date 28 Jan 2013 Page 14 of 40

15 10.4. Define a new Label by entering the following data in the Rights section. Label Owners: Test, SPLAdmin Label Editors: Test, SPLAdmin Publishers: Test, SPLPublisher Label Submitters: Test, SPLSubmitter Readers: Test, SPLReviewer The Add New SPL page displays with the newly defined Rights fields completed Define part of a new SPL by setting the following options in the Key Dates fields (select date using Calendar icon): Author Start Date: Today s date Author Stop Date: Today s date Publish Date: Today s date Submit Date: Today s date Effective Start Date: Today s date Effective Stop Date: Today s date + 5 days E-Signature Information Meaning: Created new label Logon ID: Prepopulated with OQSPLAdmin Password: password1 Comments: blank Click the Submit button. The Header information page appears. Release Date 28 Jan 2013 Page 15 of 40

16 10.6. Enter the following details for NDC. Effective time: Select using calendar icon. Company name: [OQ Company] select the Company name which is used in NDC. DUNS: [verify the same number displayed.] NDC code: Enter the Contact Party info details. Contact Party Info: Contact Person: Pam Jamison Address: 777, Sampson Street City: Mason State: Pennysylvania Country: United States Zip: : pam.jamison@acme.com Telephone: Click on save button. Click on Preview icon. A new browser window is displays the NDC labeler code details Click on Preview icon. A new browser window displays the Establishment Registrant information. Release Date 28 Jan 2013 Page 16 of 40

17 10. C. CREATES LABEL QUALIFICATION: Instructions: Qualify the basic operation of administrative features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: 10.1 From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select Create SPL sub menu item The Add New SPL page displays Define a new label by entering the following data in the associated fields. Document Type: Human prescription Drug label with Highlights Sponsor: OQ Test Sponsor Program: OQ Test Program Product Name: OQ Test Product Label Name: OQ Test Label SPL Filename: OQTestLabel Internal Version #: 1.0 FDA Version #: 1 Schema Version: FDA_SPL_Schema Stylesheet Version: Stylesheet_ Description: Sample Description The Add New SPL page displays with the newly added Label Information fields completed. Release Date 28 Jan 2013 Page 17 of 40

18 10.3 Define a new Label by entering the following data in the Rights section. Label Owners: Test, SPLAdmin Label Authors: Test, SPLAuthor Product data author: Test, SPLPDAuthor Approval Cycles: Sequential Approvers: Test, SPLApprover Publishers: Test, SPLPublisher Submitters: Test, SPLSubmitter Readers: Test, SPLReviewer The Add New Label page displays with the newly defined Rights fields completed Define part of a new Label by setting the following options in the Key Dates fields (select date using Calendar icon): Author Start Date: Today s date Author Stop Date: Today s date Approve Start Date: Today s date Approve Stop Date: Today s date Publish Date: Today s date Submit Date: Today s date Effective Start Date: Today s date Effective Stop Date: Today s date + 5 days Department name: Test dept. Department number: [blank] Meeting date: today s date Time zone: [blank] E-Signature Information Meaning: Created new label Logon ID: Prepopulated with OQSPLAdmin Password: password1 Comments: blank Click the Submit button. The SPL Label Manager page appears. Release Date 28 Jan 2013 Page 18 of 40

19 Comments: Section Reviewed By: Date: Release Date 28 Jan 2013 Page 19 of 40

20 11. SPL DRUG LISTING DATA & NARRATIVE CONTENT QUALIFICATION Instructions: Qualify the basic operation of administrative features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: Log off the active account and logon to PharmaReady using the DLD Author account with these credentials: Logon ID: OQSPLPDAuthor Password: password The My Preferences page displays with the following message: Your password has expired. Please enter a new password On the My Preferences page, enter a new password for the SPLPDAuthor account by entering the following fields. Current Password: password New Password: password1 Confirm New Password: password1 Click the Submit button. The User is forced to change the password using the My Preferences page and, when the new password is submitted, the PharmaReady Home page displays From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select the work with SPL sub menu In the Document type drop down select Human prescription Drug label with Highlights Click the > symbol next to OQ Test Label to expand the listing, then click the icon under the Authoring column The SPL Label Manager page displays. Release Date 28 Jan 2013 Page 20 of 40

21 11.4. Click the Product Data Elements tab. The editing pane is replaced with the Author Drug Listing Data pane Create new drug listing data by entering the following values in the associated fields, then click the Save button. Drug Product Type: Drug Product(s)/Multicomponent drug(s) product(s) Effective Time: Today s Date Proprietary Name: CLOZAPINE TABLETS Proprietary Name Suffix: [None] Generic Name: CLOZAPINE TABLETS Product Code: Dosage Form: CAPSULE The new values are displayed in the associated fields, and a new folder entitled CLOZAPINE TABLETS [ is added to the tree view. Release Date 28 Jan 2013 Page 21 of 40

22 11.6. Click the Active Ingredient subfolder and enter the following values in the associated fields, then click the Add button. Active Ingredient Name: Clozapine Active Ingredient Code: J60AR2IKIC Active Moiety Name: Clozapine Active Moiety Code: J60AR2IKIC Numerator: 25 Numerator Unit: MILLIGRAM Denominator:1 Denominator Unit: Tablet A new ingredient listing is added to the table at the bottom, and a new subfolder entitled Clozapine 25 MILLIGRAM is added to the tree view Click the Inactive Ingredient subfolder and enter the following values in the associated fields, then click the Add button. Inactive Ingredient Name: Povidone Active Moiety Name: FZ989GH94E A new ingredient listing is added to the table at the bottom, and a new subfolder entitled Povidone is added to the tree view Click the Packaging subfolder and enter the following values in the associated fields, then click the Add button. NDC Code: 12 Package Type: BOTTLE Numerator: 25 Numerator Unit: MILLIGRAM A new package listing is added to the table at the bottom, and a new subfolder entitled BOTTLE 25 MILLIGRAM [12] is added to the tree view. Release Date 28 Jan 2013 Page 22 of 40

23 11.9. Click on Marketing Category subfolder and enter the following values in the associated fields, then the click Add button. Marketing Category: ANDA Application Number / Monograph Citation: Status : Active Begin Market Date("low" date): Today s Date All the details of Marketing category is saved Click the Product Characteristics subfolder and enter the following values in the associated fields, then click the Save characteristics button. Route of Administration: ORAL Size: 40 Imprint: M Score: 1 DEA Schedule: CII Shape: ROUND Shape Original Text: [blank] A message appears stating Product Characteristics saved/updated successfully With the Product Characteristics subfolder still selected, enter the following values in the associated fields, and then click the Add Color button. Color: WHITE Color Original Text: [blank] A new color listing is added to the table at the bottom. Release Date 28 Jan 2013 Page 23 of 40

24 Log off the active account and logon to PharmaReady using the DLD Author account with these credentials: Logon ID: OQSPLAuthor Password: password1 The PharmaReady Home page displays Open the respective label by navigating thru the work with SPL page and click the manage icon. The SPL Label Manager Page displays Click the Header information button, Define header information by entering the following values in the associated fields. Title: These highlights do not include all the information needed to use clozapine safely and effectively. See full prescribing information for clozapine. Effective Time: [select the date] Company Name: OQ Test Company NDC Labeler Code: [select Value created during OQ] Private Labeler Code: Checked Click Add New Establishment Product code: Establishment Name: OQ Company Contact Party Info: [Contact person, Address etc. details displayed] Leave the fields in the Administration section with their default values and click the Save button. The SPL Label Manager page displays In the tree view in the left pane, select the INDICATIONS AND USAGE folder, then right click and select the Edit option. The editing pane is activated Release Date 28 Jan 2013 Page 24 of 40

25 Copy and paste the text from the INDICATIONS AND USAGE section of the source document referenced in Appendix I into the Full Prescribing Info editing pane. Click the Save button. Re-do same steps for Adverse Reactions and Drug Interactions sections. The pasted text appears in the editing pane and the Save button is disabled Select the DRUG INTERACTIONS folder and then right click the Add Section option. The SPL New Section window appears Add the following values in the associated fields and then click the Add button. Section will be added within: 7 DRUG INTERACTIONS (default) User Defined Section: 7.1 Effects of Co-Administered Drugs on Valproate Clearance Insert After: As First sub-section (default and grayed out) The Label Manager page appears and the 7.1 Effects of Co-Administered Drugs on Valproate Clearance subfolder is created beneath the DRUG INTERACTIONS folder Click the 7.1 Effects of Co-Administered Drugs on Valproate Clearance subfolder in the left-pane tree view, and then right click the Edit option. The editing pane is activated. Release Date 28 Jan 2013 Page 25 of 40

26 Copy and paste the text from the 7.1 Effects of Co- Administered Drugs on Valproate Clearance section of the source document referenced in Appendix I into the Full Prescribing Info editing pane. Click the Save button. The pasted text appears in the editing pane and the Save button is disabled Select the DRUG INTERACTIONS folder and then right click the Add Section option. The SPL New Section window appears Add the following values in the associate s fields and then click the Add button. Section will be added within: 7 DRUG INTERACTIONS (default) User Defined Section: 7.2 Effects of Valproate on Other Drugs Insert: After 7.1 Effects of Co-Administered Drugs on Valproate Clearance The Label Manager page appears and the 7.2 Effects of Valproate on Other Drugs subfolder is created beneath the DRUG INTERACTIONS folder Click the 7.2 Effects of Valproate on Other Drugs subfolder in the left-pane tree view then right click the Edit option. The editing pane is activated. Release Date 28 Jan 2013 Page 26 of 40

27 Copy and paste the text from the 7.2 Effects of Valproate on Other Drugs section of the source document referenced in Appendix I into the Full Prescribing Info editing pane. Click the Save button. The pasted text appears in the editing pane and the Save button is disabled With the 7.2 Effects of Valproate on Other Drugs subfolder selected, right click and select the Delete option. At the confirmation dialog, click OK. The 7.2 Effects of Valproate on Other Drugs folder is deleted and is no longer displayed Click the DOSAGE AND ADMINISTRATION folder in the left-pane tree view and then right click the Edit option. The editing pane is activated Copy the five-row table from Table 2 of the source document referenced in Appendix I and paste it into the editing pane The table is pasted into the editing pane Highlight the text of the first row in the table in the editing pane and then click the Table-Caption. The text for table caption text type here appears in the editing pane above the table. Release Date 28 Jan 2013 Page 27 of 40

28 Copy the title of Table 2 from the source document referenced in Appendix I and paste it into the area for table caption text type here in the editing pane. Click the Save button. The table caption is displayed above the table and the Save button is disabled Click the DOSAGE FORMS AND STRENGTH folder in the left-pane tree view and then click the Edit option. The editing pane is activated Click the Image manager button. In the Image manager window, click the Upload button and navigate to the valproicacid-fig1.jpg file by using Select button to select the image and then click the Upload button. When the filename appears in the center pane of the Image manager window, click the filename in the right hand side click the properties tab, provide the ALT text and then click the Insert button. Click the Save button. The image appears in the editing pane and the Save button is disabled Click the INDICATIONS AND USAGE folder and then Right click to select the Validate option. Continue validating all the sections added into this label. A pop-up window appears with the message The Generated XML is Valid On the SPL Label Manager page, click the Validate button. A pop-up window appears with a message stating The Generated XML is Valid. Release Date 28 Jan 2013 Page 28 of 40

29 Click OK to dismiss the pop-up window. The pop-up window should close and focus returns to the Label Manager page Click the Preview -> Preview SPL button. A new browser window appears with the contents of the label displayed Close the new browser window. The new browser window is closed and focus returns to the Label Manager page. Comments: Section Reviewed By: Date: Release Date 28 Jan 2013 Page 29 of 40

30 12. SPL APPROVE LABEL QUALIFICATION Instructions: Qualify the basic operational features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: Log off the active account and logon to PharmaReady using the SPL Admin account with these credentials: Logon ID: OQSPLAdmin Password: password1 The PharmaReady Home page appears From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select the work with SPL sub menu In the Document type drop down select Human prescription Drug label with Highlights Click the > symbol next to OQ Test Label to expand the listing and then click the icon under the Properties column. The Maintain SPL Properties page displays Click the Approve radio button in the Activity Mode section. Enter the following E-Signature values and click the Submit button. Meaning: Changed label Logon ID: Prepopulated with OQSPLAdmin Password: password1 Comments: blank The Work with Labels page displays. Release Date 28 Jan 2013 Page 30 of 40

31 12.4. Click the > symbol next to OQ Test Label to expand the listing. Verify the Status column displays Pending Approval. The correct status is displayed Log off the active account and logon to PharmaReady using the SPL Approver account with these credentials: Logon ID: OQSPLApprover Password: password The My Preferences page displays with the following message: Your password has expired. Please enter a new password On the My Preferences page, enter a new password for the SPL Approver account by entering the following fields. Current Password: password New Password: password1 Confirm New Password: password1 Click the Submit button. The User is forced to change the password using the My Preferences page and, when the new password is submitted, the PharmaReady Home page displays From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select the work with SPL sub menu In the Document type drop down select Human prescription Drug label with Highlights Click the > symbol next to OQ Test Label to expand the listing and then click the icon under the Approve column. The Approve Label page displays. Release Date 28 Jan 2013 Page 31 of 40

32 12.8. On the Approve Label page, enter the following E- Signature credentials and click the Submit button. Meaning: Approve Logon ID: Prepopulated with OQSPLApprover Password: password1 Comments: blank The Work with Labels page appears Click the > symbol next to the OQ Test Product and verify the Status column displays Approved. The status is displayed correctly Verify the Approver receives an stating similar text: Label OQ Test Label is Approved Please logon to to view this Label. The Approver receives notification indicating the label has been approved Log off the active account and logon on to PharmaReady using the default Administrative account with these credentials: Logon ID: admin Password: (password entered during IQ) The PharmaReady Home page displays. Release Date 28 Jan 2013 Page 32 of 40

33 From the PharmaReady home page Click the SPL Button to navigate SPL Home page From the Admin menu, click the Audit Log Viewer sub menu item. The Audit Log Viewer page appears Select the following values from the associated dropdown menu and click the Submit button. Type: SPL Activity: All Person: Test, SPLAdmin All SPL audit log entries initiated by the SPL Admin are displayed Verify the Audit Log Viewer contains an entry ( Edit Label Properties ) recording the Activity Mode change of the OQ Test Label. The Audit Log Viewer displays the correct entries for the Property Change of the OQ Test Label. Comments: Section Reviewed By: Date: Release Date 28 Jan 2013 Page 33 of 40

34 13. SPL PUBLISH LABEL QUALIFICATION Instructions: Qualify the basic operational features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided. Performed by: by: Date: Date: Log off the active account and logon to PharmaReady using the SPL Admin account with these credentials: Logon ID: OQSPLAdmin Password: password1 The PharmaReady home page appears From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the SPL menu, select the Work with Labels sub menu item. Click the > symbol next to OQ Test Label to expand the listing and then click the icon under the Properties column. The Maintain SPL Properties page displays Click the Publish radio button in the Activity Mode section. Enter the following E-Signature values and click the Submit button. Meaning: Changed label Logon ID: Prepopulated with OQSPLAdmin Password: password1 Comments: blank The Work with SPL page displays Click the + symbol next to the OQ Test Product and verify the Status column displays Pending Publishing. That status is displayed correctly. Release Date 28 Jan 2013 Page 34 of 40

35 13.5. Log off the active account and logon to PharmaReady using the SPL Publisher account with these credentials: Logon ID: OQSPLPublisher Password: password The My Preferences page displays with the following message: Your password has expired. Please enter a new password On the My Preferences page, enter a new password for the SPL Publisher account by entering the following fields. Current Password: password New Password: password1 Confirm New Password: password1 Click the Submit button. The User is forced to change the password using the My Preferences page and, when the new password is submitted, the PharmaReady Home page displays From the SPL menu, select the Work with Labels sub menu item. Click the > symbol next to OQ Test Label to expand the listing and then click the icon under the Publish column. The Publish Label page displays On the Publish Label page, enter the following E- Signature credentials and click the Submit button. Meaning: Publish Logon ID: Prepopulated with OQSPLPublisher Password: password1 Comments: blank The Work with SPL page appears. Release Date 28 Jan 2013 Page 35 of 40

36 13.9. Click the > symbol next to the OQ Test Product and verify the Status column displays Published. That status is displayed correctly Verify the Publisher receives an stating similar text: Label OQ Test Label is Published. Please logon to to view this Label The Publisher receives notification indicating the label has been published Log off the active account and logon on to PharmaReady using the default Administrative account with these credentials: Logon ID: admin Password: (password entered during IQ) The PharmaReady Home page displays From the PharmaReady home page Click the SPL Button to navigate SPL Home page. From the Admin menu, click the Audit Log Viewer sub menu item. The Audit Log Viewer page appears. Release Date 28 Jan 2013 Page 36 of 40

37 Select the following values from the associated dropdown menu and click the Submit button. Type: SPL Activity: All Person: Test, SPLAdmin All SPL audit log entries initiated by the SPL Admin are displayed Verify the Audit Log Viewer contains an entry ( Edit Label Properties ) recording the Activity Mode change of the OQ Test Label. The Audit Log Viewer displays the correct entries for the Property Change of the OQ Test Label. Comments: Section Reviewed By: Date: Release Date 28 Jan 2013 Page 37 of 40

38 POST OQ- APPROVAL FROM CUSTOMER The signatures below indicate approval of this executed protocol by TAKE Solutions. Name Signature Company Date Release Date 28 Jan 2013 Page 38 of 40

39 APPENDIX I SPL EXAMPLE ZIP FILE Release Date 28 Jan 2013 Page 39 of 40

40 14. PROTOCOL DEVIATION REPORT Print as many copies of this page as necessary. Describe each Deviation on a separate page. Number: Date: Protocol Section: Step #: Deviation: Initiator: Date: Corrective Action: Resolved By: Section Reviewed By: Date: Date: Release Date 28 Jan 2013 Page 40 of 40