Operational Qualification - Admin

PharmaReady Version 5.0 DMS Admin Setup Performance Qualification Software Release Date – 6Mar 2012 Document Number: OQ82 Doc Version 1.0 May 21, 2012

Company Name: ______

Address: ______

______

Project Name: ______

Server Name: ______

Server Location: ______

PQ Executed By:

______Name / Title / Representing

______Signature / Date PharmaReady Version 5.0 Performance Qualification – DMS Admin

TABLE OF CONTENTS 1. Objective 3 2. Procedure 3 2.1. Prerequisites 3 2.2. Execution 3 2.3. Protocol Completion 4 2.4. Acceptance Criteria 4 3. Document Control 5 4. Revision History 6 5. Pre-PQ Approval from Customer 6 6. PQ Roles and Responsibilities 6 7. Execution/Review Signature Verification 7 8. DMS Admin Logon Qualification 8 9. DMS System Settings Qualification 9 10. DMS Library Administration Qualification 13 11. DMS Category Administration Qualification 23 12. DMS Site Administration Qualification 25 13. DMS Department Administration Qualification 26 14. DMS Project Administration Qualification 27 15. DMS Reminder Administration Qualification 29 16. DMS People Administration Qualification 31 17. DMS Reader Group Administration Qualification 35 18. DMS Reviewer Group Administration Qualification 37 19. DMS Approver Group Administration Qualification 39 20. DMS Document Properties Template Administration Qualification 41 21. DMS Audit Log Administration Qualification 46 22. Post-Execution Approval 47 23. Protocol Deviation Report 48

Release Date – 06 Mar 2012 Page 2 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 1 OBJECTIVE This protocol outlines the requirements for the Performance Qualification (PQ) of the administrative setup functions of the PharmaReady Document Management System (DMS) version 5.0. The PQ 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 administrative 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 administrative setup data for use in change control and to aid in troubleshooting. This protocol is a part of the overall validation effort for PharmaReady DMS version 5.0.

2 PROCEDURE 3 Prerequisites  All hardware, software, and infrastructure requirements must be completed.  All Installation Qualifications protocols have successfully passed execution.  The testers’ computers have been validated by executing the IQ-client protocol  Data within the PQ will be used as written for the first execution of this PQ. In order to ensure uniqueness for any subsequent executions of this PQ, a letter will be pre-pended to all data values starting with “A” for the second execution, “B” for the third, etc.

4 Execution  Print the Performance Qualification document.  Execute the Performance Qualification on the PharmaReady server.  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 “DMS Screen Capture Document – Performance Qualification, DMS-Admin”.  The “DMS Screen Capture Document” will be labeled with the following information: o Header contains: . Project Name: . Version#: . Test Case Name: 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 “DMS Screen Capture Document” to the back of the applicable test case.

Tester(s)  The Tester(s) writes their name in the “Performed by” field at the beginning of each section. If there are two testers involved in executing sections of a chapter, both their names can be written against “Performed by” and both can sign off on the section  The Tester(s) enter(s) Pass or Fail in the “Observed Results As Expected” column. If the expected results are not as expected write a deviation report. The tester(s) should write a deviation report when: o The protocol step is inaccurate. o The data is entered incorrectly. o A screen shot was not taken for a required step.  The Tester(s) enter(s) their initials and the date in the “Tested & Verified By/Date” column to indicate an acceptable result.  The Tester(s) will label each screen print with the section identified, corresponding to results.

Release Date – 06 Mar 2012 Page 3 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin

Verifier  The Verifier verifies the execution of the PQ and ensures all screen captures reflect the correct data.  It is not necessary for the verifier to be sitting alongside with the tester(s) while executing the PQ.  The Verifier reviews the documentation to ensure all sections are completed.  The Verifier writes their name in the “Verified 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.

5 Protocol Completion  After completing the execution of the PQ by Inno Pharma, they will provide a photocopy of the completed PQ document and all supporting documentation to TAKE Solutions for support purposes.  Inno Pharma will keep the original executed PQ documents for their internal audit purposes.  After completing the execution of the Performance Qualification, submit the completed protocol with supporting data and all deviation reports to the Quality Assurance Director / Manager.  .

6 Acceptance Criteria  Criteria for accepting the Performance Qualification DMS Admin phase as being complete are: o The PQ 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 PQ document has been verified by a witness who might or might not have been sitting alongside with the testers. o The PQ document has been reviewed by quality assurance or designee. o

Approver  The Inno Pharma 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 DMS Admin PQ indicates that the criteria outlined in this protocol have been met and indicates acceptance of the system.

Release Date – 06 Mar 2012 Page 4 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 7 DOCUMENT CONTROL Authored by: Reviewed by: Approved by:

Baskar Balaji, Date Vijay Srinivasan Date QA Person Date Implementation Sr. Manager Engineer

8 REVISION HISTORY Version Date Author Remarks 1.0 20 June 2012 Baskar Balaji Initial Final Version.

9 PRE-PQ APPROVAL FROM CUSTOMER The signatures below indicate approval of this PQ for execution by authorized customer staff. This should be filled and signed before the PQ can be executed Name/Title Signature Date

10 PQ ROLES AND RESPONSIBILITIES Indicate each person’s responsibility in the performance qualification protocol process. This should be filled before the PQ can be executed. Role (Tester, Verifier, Name Title Reviewer, Approver)

11 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. This should be filled and signed before the PQ can be executed Printed Name Signature and Initials Affiliation

Release Date – 06 Mar 2012 Page 7 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 12 DMS ADMIN LOGON 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: ______Date: ______Verified by: ______Date: ______

Are Observed Results Tested & As Expected? (Note Verified Operation Any Discrepancies) By/Date

13 At the Customer workstation, logon to PharmaReady using the default Administrative account with these credentials:  Logon ID: admin  Password: password Expected Result: The PharmaReady Home page displays.

14 Under the Admin menu, click the My Preferences sub menu item.  On the My Preferences page change the Number of Rows to 20.  Check the Email Notify checkbox.  Change the email address to a valid email address.

TAKE SCREEN SHOT Click the Submit button. Expected Result: The PharmaReady Home page displays.

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 8 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 15 DMS SYSTEM SETTINGS 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: ______Date: ______Verified by: ______Date: ______

16 From the Admin menu, click the System Settings sub menu item to access the System Settings page. Expected Result: The General tab of the System Settings page displays.

17 Define the Customizable Page Text by entering the following data in the applicable fields.  Central Welcome Text: Welcome Text  Central Help Text: Help Text  Logon Text: Logon Text Expected Result: The General tab of the System Setting page displays with the Customizable Page Text fields containing the above data.

18 Verify the following Global Settings fields have values entered from the Installation Qualification document.  Email Alias ______ Notification Email ______ Invalid Logon Notify ______ Default Domain ______ Default Username ______ Default Password ______

If In-Place Editing is used:  Local Save Directory ______ Remote Save Directory ______Expected Result: The General tab of the System Settings page displays with the above fields completed from the IQ document.

19 Verify the following Global Settings fields have the following data in the applicable fields.  Password Change: 0, 7, 14, 30, 60, 90, 180, 360  Number of Attempts: 0, 3, 4, 5, 6  Default Printer:  People Auto Update Interval: 0  Action Items Validation Interval: 0  Default Date Format: a) M/d/yyyy b) MM/dd/yyyy c) dd/MM/yyyy d) yyyy/MM/dd e) yyyy-MM-dd f) dd-MMM-yyyy g) MMM-dd-yyyy  Default Time Format: a) hh:mm A b) hh:mm AM c) hh:mm d) hh:mm A +-GMT e) hh:mm AM +-GMT f) hh:mm+-GMT Expected Result: The General tab of the System Settings page displays with the Global Settings fields with the above data.

20 Select/Enter the following values in the Global Settings fields.  Password Change: 90  Number of Attempts: 3  Default Printer:  People Auto Update Interval: 0  Action Items Validation Interval: 0 a) Default Date Format: dd-MMM-yyyy   Default Time Format: hh:mm A Expected Result: The General tab of the System Settings page displays with the Global Settings fields containing the above data.

21 Under the General E-Signature Settings section, verify the Regulatory Identifier checkbox is blank and that no fields appear in the Meanings column. Expected Result: The General tab of the System Settings page displays with the Regulatory Identifier checkbox blank and with no fields in the Meanings column.

TAKE SCREEN SHOT (include 9.2 – 9.6)

22 Enter a valid email address in the Send Test EmailTo field. Click the Send Test Email button. Click the Submit button. Expected Result: The system sends a test email to the designated email address. The email message is received by the recipient.

TAKE SCREEN SHOT OR ATTACH EMAIL

23 On the PharmaReady Home Page, Click on the DMS button and Select System Settings from Admin menu. Expected Result: The System Settings page displays.

24 Verify the following fields have the following data in the applicable fields.  Initial Version Number: 0.0  Doc Auto-Num Enabled checkbox: blank  Doc Auto-Num Prefix: blank  Doc Auto-Num Counter: 1000 Expected Result: The System Settings page displays with the above fields and data.

25 Verify no fields appear in the Prompt and Entry Required columns of the Custom Document Property Fields section.

TAKE SCREEN SHOT (include 9.8 – 9.10) Click the Submit button. Expected Result: No fields appear in the Prompt and Entry Required columns. The System Settings page closes, and the Central page displays.

Release Date – 06 Mar 2012 Page 11 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 12 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 26 DMS LIBRARY ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

27 From the Admin menu, select the Libraries sub menu item to access the Admin Libraries page, and then click the Add a New Library button. Expected Result: The Add New Library page displays.

28 Define part of a new Library by entering the following data in the Library Information associated fields.  Library Name: QualityAssurance  Description: QA Library for Inno Pharma  Active: checked  Date Added: blank  Last Changed: blank  Default Doc Properties Template: blank  Doc Auto Num Enabled: checked  Doc Auto Num Prefix: QA-  Doc Auto Num Counter: 0 Expected Result: The Add New Library page displays with the newly added Library Information fields completed.

29 Define part of a new library by setting the following option in the Workflow Settings fields.  Require Approval to Publish Documents: checked  Require Child Documents be Published for Virtual Document to be Published: blank  Include Document Description in Workflow Emails: blank  Include Check in/Out Comments in the Review Email: checked.  Include Review Comments in Review Complete Email: checked.  Include Approve Comments in Approve Complete Email: checked Expected Result: The Add New Library page displays with the Workflow options all checked.

30 Define part of a new Library by setting the following options in the PDF Publishing Defaults fields:  Published Watermark Text Field: Controlled Copy  Include Watermark Text: checked  Include version and published Date watermark checkbox: checked  Create Bookmarks from Style Settings checkbox: blank  Append Document Control information page checkbox: blank  Prevent PDF from being Printed checkbox: blank  Prevent PDF contents from being Copied or Saved as another Format checkbox: blank  Include Printed Date in Document: checked Expected Result: The Add New Library page displays with the PDF Publishing Defaults checkboxes checked accordingly.

31 In the E-Signature Setting section, click the checkbox next to the Check-in action and then click the Add button. Expected Result: The Meanings field for the Check-in action appears.

32 Enter “Checked in original doc” in the Check-in Meanings field. Click the Check-in Add button two more times and enter the following meanings:  Checked in different doc  Made edits to doc Expected Result: The Add New Library page displays with the newly added Check-In Meanings fields completed.

33 In the E-Signature Setting section, click the checkbox next to the Change Document Properties action and then click the Add button. Expected Result: The Meanings field for the Change Document Properties action appears.

34 Enter “Changed activity mode” in the Change Document Properties Meanings field. Click the Change Document Properties Add button two more times and enter the following meanings:  Changed key dates section  Changed “other” Expected Result: The Add New Library page displays with the newly added Change Document Properties Meanings fields completed.

35 In the E-Signature Setting section, click the checkbox next to the Approve action and then click the Add button. Expected Result: The Meanings field for the Approve action appears.

36 Enter “Approved without Comment” in the Approve Meanings field. Click the Approve Add button two more times and enter the following meanings:  Approved with Comments  Did not Approve Expected Result: The Add New Library page displays with the newly added Approve Meanings fields completed.

37 In the E-Signature Setting section, click the checkbox next to the Publish action and then click the Add button. Expected Result: The Meanings field for the Publish action appears.

38 Enter “Published in PDF” in the Publish Meanings field. Click the Publish Add button five more times and enter the following meanings:  Published in original format  Changed effective dates  Changed training dates  Checked training document checkbox  Checked expire previous versions checkbox Expected Result: The Add New Library page displays with the newly added Publish Meanings fields completed.

39 In the E-Signature Setting section, click the checkbox next to the Verify Read action and then click the Add button. Expected Result: The Meanings field for the Verify Read action appears.

40 Enter “I verify that I have read this document.” in the Verify Read Meanings field. Click the Verify Read Add button one more time and enter the following meaning:  I have read and will implement the procedures outlined in this document. Expected Result: The Add New Library page displays with the newly added Verify Read Meanings fields completed.

TAKE SCREEN SHOT (include 10.6, 10.8, 10.10, 10.12, 10.14)

41 In the Custom Document Property Fields section, click the Add button next to Text Field. Expected Result: Fields appears under the Field Label and Prompt columns for the Text Field property.

42 Enter the following data in the Custom Document Properties Fields for the Text Field property:  Text Field checkbox: checked  Text Field Label: Reason for doc change  Text Field Prompt: Enter in sentence format  Text Field Entry Required checkbox: checked

Expected Result: The Add New Library page displays with the newly added Text Field Custom Document Property Fields.

43 In the Custom Document Property Fields section, click the Add button next to Numeric Field. Expected Result: Fields appears under the Field Label and Prompt columns for the Numeric Field property.

44 Enter the following data in the Custom Document Properties Fields for the Numeric Field property:  Numeric Field checkbox: checked  Numeric Field Label: Previous doc number  Numeric Field Prompt: Enter legacy doc number  Numeric Field Entry Required checkbox: blank

Expected Result: The Add New Library page displays with the newly added Numeric Field Custom Document Property Fields.

45 In the Custom Document Property Fields section, click the Add button next to Date/Time Field. Expected Result: Fields appears under the Field Label and Prompt columns for the Date/Time Field property.

46 Enter the following data in the Custom Document Properties Fields for the Date/Time Field property:  Date/Time Field checkbox: checked  Date/Time Field Label: SOP training stop date  Date/Time Field Prompt: Enter the date the SOP training period ends  Date/Time Field Entry Required checkbox: checked

Expected Result: The Add New Library page displays with the newly added Date/Time Field Custom Document Property Fields.

47 In the Custom Document Property Fields section, click the Add button next to Dropdown Field. Expected Result: Fields appears under the Field Label and Prompt columns for the Drop Down Field property. A Drop Down List Data field appears.

48 Enter the following data in the Custom Document Properties Fields for the Drop Down Field property.  Drop Down Field checkbox: Checked  Drop Down Field Label: Species  Drop Down Field Prompt: Select species type from list  Drop Down Field Entry Required checkbox: blank  Drop Down List Data: Mice; Cat; Dog; Other

TAKE SCREEN SHOT (include 10.16, 10.18, 10.20, 10.22) Click the Submit button. Expected Result: The Add New Library page displays with the newly added Drop Down Field Custom Document Property Fields. The Admin Libraries page displays with the newly added Library in the list.

TAKE SCREEN SHOT OF ADMIN LIBRARIES PAGE WITH NEW LIBRARY APPEARING

49 Click the Library name in the Name column to open the Maintain Library page. Click the Maintain Folders button. Expected Result: The Folder Maintenance page displays.

50 While the “QualityAssurance” folder in the tree view is highlighted, click the Add a Folder button Expected Result: The text NEW FOLDER appears in the Folder Name and Description fields.

51 Create the sub folder by entering the following data in the associated fields.  Folder Name: Audits  Description: Audits  Comment: blank  Active: checked  Date Added: Today’s date populates  Last Changed: Today’s date populates  Document Count: 0

Click the Submit Folder Changes button. Expected Result: The Folder Maintenance page displays the Audits folder under the applicable library in the tree view.

TAKE SCREEN SHOT

Release Date – 06 Mar 2012 Page 18 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 52 Click to highlight the “QualityAssurance” folder in the tree view and click the Add a Folder button. Create 2 additional sub folders by entering the following data in the associated fields.  Folder Name: Change Control (CC)  Description: Change Control (CC)  Comment: blank  Active: checked  Date Added: Today’s date populates  Last Changed: Today’s date populates  Document Count: 0

 Folder Name: Complaints  Description: Complaints  Comment: blank  Active: checked  Date Added: Today’s date populates  Last Changed: Today’s date populates  Document Count: 0

Click the Submit Folder Changes button. Expected Result: The Folder Maintenance page displays the Change Control (CC) and Complaints under the applicable library in the tree view.

TAKE SCREEN SHOT

Release Date – 06 Mar 2012 Page 19 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 53 Click to highlight Audits in the tree view and click the Add a Folder button. Create 4 additional sub folders by entering the following data in the associated fields.  Folder Name: CAPA  Description: CAPA  Comment: blank  Active: checked  Date Added: Today’s date populates  Last Changed: Today’s date populates  Document Count: 0

 Folder Name: Checklists  Description: Checklists  Comment: blank  Active: checked  Date Added: Today’s date populates  Last Changed: Today’s date populates  Document Count: 0

 Folder Name: Reports  Description: Reports  Comment: blank  Active: checked  Date Added: Today’s date populates  Last Changed: Today’s date populates  Document Count: 0

 Folder Name: Schedules  Description: Schedules  Comment: blank  Active: checked  Date Added: Today’s date populates  Last Changed: Today’s date populates  Document Count: 0

Click the Submit Folder Changes button. Expected Result: The Audits folder will have the four sub folders seen in the tree view.

TAKE SCREEN SHOT

54 Close the Folder Maintenance page by clicking the Return to Maintain Library button. Expected Result: The Maintain Library page displays.

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 21 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 55 DMS CATEGORY ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

56 From the Admin menu, select the Categories sub menu item to access the Admin Categories page then click the Add a New Category button. Expected Result: The Add New Category page displays.

57 Define a new Category by entering the following data in the associated Category Information fields.  Category Name: Checklists  Description: Checklists  Active: checked  Date Added: blank  Last Changed: blank  Default Doc Properties Template: blank  Doc Auto-Num Enabled: checked  Doc Auto-Num Prefix: CHKL-  Doc Auto-Num Counter: 1000 Expected Result: The Add NewCategory page displays with the newly added Category Information fields completed.

58 In the Custom Document Property Fields section, click the Add button next to Text Field. Expected Result: Fields appears under the Field Label and Prompt columns for the Text Field property.

59 Enter the following data in the Custom Document Properties Fields for the Text Field property:  Text Field checkbox: checked  Text Field Label: Dept Category  Text Field Prompt: Enter Dept Code  Text Field Entry Required checkbox: blank

Expected Result: The Add New Category page displays with the newly added Text Field Custom Document Property Fields.

60 Click the Submit button. Expected Result: The Admin Categories page displays with the newly added Category in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 23 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 61 DMS SITE ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

62 Go to PharmaReady Home Page, Under the Admin menu, click the Sites sub menu item to access the Admin Sites page, and then click the Add a New Site button. Expected Result: The Add New Site page displays.

63 Define a new Site by entering the following data in the associated fields.  Site Code: Inno Pharma  Description: Inno Pharma  Active: checked Expected Result: The Add New Sites page displays with the entered data. TAKE SCREEN SHOT

64 Click the Submit button. Expected Result: The Admin Sites page displays with the newly added Site in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 24 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 65 DMS DEPARTMENT ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

66 Under the Admin menu, click the Departments sub menu item to access the Admin Departments page, and then click the Add a New Dept button. Expected Result: The Add New Department page displays.

67 Define a new Department by entering the following data in the associated fields.  Department Code: Quality Assurance  Active: checked  Description: Quality Assurance  Manager: blank  Site: Inno Pharma(Inno Pharma) Expected Result: The Add New Departments page displays with the entered data.

TAKE SCREEN SHOT

68 Click the Submit button. Expected Result: The Admin Departments page displays with the newly added department in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 25 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 69 DMS PROJECT ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

70 Under the Admin menu, click the Projects sub menu item to access the Admin Projects page, and then click the Add a New Project button. Expected Result: The Add New Project page displays.

71 Define a new Project by entering the following data in the associated fields.  Project Name: DMS-PQ  Active: checked  Description: DMS-PQ  Project Number: PQ  Department: Quality Assurance  Start Date: today’s date  Stop Date: today’s date  Project Manager: blank  Project Manager Other: blank  Project Executive: blank  Project Executive Other: blank  Assigned People: blank Expected Result: The Add New Projects page displays with the entered data

TAKE SCREEN SHOT

72 Click the Submit button. Expected Result: The Admin Projects page displays with the newly added project in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 27 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 73 DMS REMINDER ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

74 Under the Admin menu, click the Reminder sub menu item to access the Admin Reminders page, and then click the Add a New Reminder button. Expected Result: The Add New Reminder page displays.

75 Verify the following Reminder Information fields have the following default data in the applicable fields.  Reminder Type: 1. Approval of Working Document 2. Assessment from DMS/Document 3. Document Read 4. Document Read Verify 5. Document Read within Training Dates 6. Manual Training Specification Read/Assessment 7. Document Checked-Out 8. Published Document Due for Review 9. Review of Working Document 10. Training Course/Assessment 11. Training DMS Document Read/Verify Read/Assessment 12. Training Event 13. General Reminder  Library: All Active DMS Libraries  Department: All Active DMS Departments  Days Out to Send: -1  Reminder Interval Days:-1 Expected Result: The Add New Reminder page fields have the correct default data.

76 Define a new Reminder by entering the following data in the associated fields.  Reminder Name: Review Reminder for QA docs  Description: Review Reminder for QAdocs  Active: checked  CC Supervisor: checked  Reminder Type: Review of Working Document  Library: Quality Assurance  Department: All  Days Out to Send Reminder:-1  Reminder Interval Days:1  Reminder Email Subject: Review Reminder for QA docs  Reminder Email Message: This is a Review Reminder for the Document created in the QA library. Expected Result: The Add New Reminders page displays with the entered data.

TAKE SCREEN SHOT

77 Click the Submit button. Expected Result: The Admin Reminders page displays with the newly added reminder in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 29 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 78 DMS PEOPLE ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

79 From the Admin menu, click the People sub menu item to access the Admin People page then click the Add a New Person button. Expected Result: The Add New People page displays.

80 Define a new Person manually by entering the following data in the associated fields.  Logon ID: PQUser1  Active checkbox: checked  First Name: PQ  Last Name: User 1  Eff. End Date: Today’s date + 7  Last Logon:blank  Unit: blank  Email: <>  Phone: blank  Phone 2: blank  AD Authenticate checkbox:blank  AD Domain: blank  In-Place Editing: blank  Department: Quality Assurance  Supervisor: blank  Default Printer: blank  Add a New Role a) Type: System b) Library: [read only] c) Department: [read only] d) Role Name: Administrator

 Assigned Reader Groups: blank  Assigned Projects: DMS  Password: password  Confirm Password: password  Locked checkbox: blank  Clear All Action Items checkbox: blank  Send DMSEmail Notification checkbox: blank  Send TRMS Email Notification checkbox: blank

TAKE SCREEN SHOT Click the Submit button. Expected Result: The Admin People page displays with the newly added Person in the list.

81 On the Admin People page, click the Add a New Person button. Expected Result: The Add New People page displays.

82 Define a new Person manually by entering the following data in the associated fields.  Logon ID: PQUser2  Active checkbox: checked  First Name: PQ  Last Name: User 2  Eff. End Date: Today’s date + 7  Last Logon: blank  Unit: blank  Email: <>  Phone: blank  Phone 2: blank  AD Authenticate checkbox: checked  AD Domain: blank  In-Place Editing: blank  Department: Quality Assurance  Supervisor: blank  Default Printer: blank  Add a New Role a) Type: DMS b) Library: Quality Assurance c) Department: [read only] d) Role Name: Library Administrator

 Assigned Reader Groups: blank  Assigned Projects: PQ-DMS  Locked checkbox: blank  Clear All Action Items checkbox: blank  Send DMS Email Notification checkbox: blank  Send TRMS Email Notification checkbox: blank

TAKE SCREEN SHOT Click the Submit button. Expected Result: The Admin People page displays with the newly added Person in the list.

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 33 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 83 DMS READER GROUP ADMINISTRATION QUALIFICATION

84 Go to PharmaReady DMS Home Page, From the Admin menu, select Groups Reader Groups sub menu item to access the Admin Reader Groups page, and then click the Add a New Reader Group button. Expected Result: The Add New Reader Group page displays.

85 Define a new Reader Group by entering the following data in the associated fields.  Group Name: QA-Reader Group  Description: QA Reader Group  Active: checked  Date Added: blank  Last Changed: blank  Library Name:QualityAssurance  Add Person: PQ User 1 and PQ user 2  Assigned Person: PQ User 1 and PQ user 2 Expected Result: The Add New Reader Group page displays with the entered data.

TAKE SCREEN SHOT

86 Click the Submit button. Expected Result: The Admin Reader Groups page displays with the newly added Reader Group in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 35 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 87 DMS REVIEWER GROUP ADMINISTRATION QUALIFICATION

88 Go to PharmaReady DMS Home Page, From the Admin menu, select Groups Reviewer Groups sub menu item to access the Admin Reviewer Groups page, and then click the Add a New Reviewer Group button. Expected Result: The Add New Reviewer Group page displays.

89 Define a new Reviewer Group by entering the following data in the associated fields.  Group Name: QA-ReviewerGroup  Description: QA Reviewer Group  Active: checked  Date Added: blank  Last Changed: blank  Library Name:QualityAssurance  Add Person: PQ User 1 and PQ user 2  Assigned Person: PQ User 1 and PQ user 2 Expected Result: The Add New Reviewer Group page displays with the entered data.

TAKE SCREEN SHOT

90 Click the Submit button. Expected Result: The Admin Reviewer Groups page displays with the newly added Reviewer Group in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 37 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 91 DMS APPROVER GROUP ADMINISTRATION QUALIFICATION

92 Go to PharmaReady DMS Home Page, From the Admin menu, select Groups Approver Groups sub menu item to access the Admin Approver Groups page, and then click the Add a New Approver Group button. Expected Result: The Add New Approver Group page displays.

93 Define a new Approver Group by entering the following data in the associated fields.  Group Name: QA-ApproverGroup  Description: QA Approver Group  Active: checked  Date Added: blank  Last Changed: blank  Library Name:QualityAssurance  Add Person: PQ User 1 and PQ user 2  Assigned Person: PQ User 1 and PQ user 2 Expected Result: The Add New Approver Group page displays with the entered data.

TAKE SCREEN SHOT

94 Click the Submit button. Expected Result: The Admin Approver Groups page displays with the newly added Approver Group in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 39 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 95 DMS DOCUMENT PROPERTIES TEMPLATE ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

Are Observed Results As Tested & Expected? (Note Verified Operation Any Discrepancies) By/Date

96 Go to PharmaReady DMS Home Page, From the Admin menu; select the Doc Prop Templates sub menu item to access the Admin Doc Prop Templates page. Leave the Library and Category drop-down lists selection to All, and then click the Add a New Document Properties Template button. Expected Result: The Document Properties Template page displays.

97 Define a new Document Properties Template by entering the following data in the associated fields. General Info Tab  Template Name: QA - Doc Prop Template  Category: All  Library: QualityAssurance  Active checkbox: checked  Date Added: today’s date  Last Changed: blank  Changed By: blank

 New Version Number: blank  Title: blank  Description: blank  Keywords: Quality Assurance  Activity Mode: Edit Expected Result: The Add New Doc Prop Template page displays with the newly added General information.

TAKE SCREEN SHOT

98 Define a new Document Properties Template by entering the following data in the associated fields by selecting the Key Dates tab. Key Dates Tab  Create Start Date: 0  Create Stop Date: 1  Review Start Date: 2  Review Stop Date: 3  Approve Start Date: 4  Approve Stop Date: 5  Publish Date: -999  Training Start Date: 0  Training Stop Date: 10  Effective Start Date: 0  Effective Stop Date: 365  Distribute Date: 7  Date Due Review: 300  Retention Period: 1 Year from Effective Stop Date Expected Result: The Add New Doc Prop Template page displays with the newly added Key Dates Information.

TAKE SCREEN SHOT

99 Define a new Document Properties Template by entering the following data in the associated fields by selecting the Authors/Owners tab. Authors/Owners Tab  Assigned Document Authors: PQ User 1  Assigned Document Owner: PQ User 1 Expected Result: The Add New Doc Prop Template page displays with the applicable Author and Owner selected in the Authors/Owners tab.

TAKE SCREEN SHOT

100 Define a new Document Properties Template by entering the following data in the associated fields by selecting the Reviewers tab. Reviewers Tab  Basic Cycle: Sequential  Document Reviewers: Blank  Document Reviewers Group: QA-ReviewerGroup  Extended Cycle: None

Expected Result: The Add New Doc Prop Template page displays with the applicable reviewer selected in the Reviewers tab.

TAKE SCREEN SHOT

101 Define a new Document Properties Template by entering the following data in the associated fields by selecting the Approval tab. Approval Tab  Basic Cycle: Parallel  Document Reviewers: Blank  Document Reviewers Group: QA-ApproverGroup  Extended Cycle: None Expected Result: The Add New Doc Prop Template page displays with the applicable approver selected in the Approval tab.

TAKE SCREEN SHOT

102 Define a new Document Properties Template by entering the following data in the associated fields by selecting the Readers tab. Readers Tab  Add a New Reader a) Type:Reader Group b) Reader Name: QA-ReaderGroup c) View Document: checked d) Read Required: checked e) Verify Read Required: checked f) Assessment: blank Expected Result: The Add New Doc Prop Template page displays with the applicable Readers selected in the Readers tab

TAKE SCREEN SHOT

103 Click the Submit button. Expected Result: The Admin Doc Prop Templates page displays with the newly added document property template in the list.

104 Reopen the QA - Doc Prop Template by clicking on the hyperlinked name and continue to define the Document Properties Template by entering the following data in the associated fields. Other Properties Tab

 Reason for doc change: Updated PQ document information.  Previous doc number: PQ-  SOP Training Stop Date: today’s date  Species: Mice

 Projects: PQ-DMS

 Cabinet: Cabinet 1  Drawer: Drawer 2  Shelf & Bin fields: blank  Disk & Filename fields: blank  Reel & Frames fields: blank  Image ID: blank  Site: File Room

Expected Result: The Add New Doc Prop Templates page contains the entered data.

TAKE SCREEN SHOT

105 Click the Submit button. Expected Result: The Admin Doc Prop Templates page displays with the newly added document property template in the list.

TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 44 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 106 DMS AUDIT LOG ADMINISTRATION 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: ______Date: ______Verified by: ______Date: ______

107 From the Admin menu, select the Audit Log Viewer sub menu item to access the Audit Log Viewer. Expected Result: The Audit Log Viewer page displays.

108 Verify the audit log has records of all People that are created in the system by selecting the following data.  Type: User  Activity: ALL  Person:Admin, Admin

Click View Report and verify the following entries appear. New User: PQ User 1 New User: PQ User 2

Expected Result: The Audit Log Viewer page filters the data and displays (at least) the above records. TAKE SCREEN SHOT

Comments:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 45 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 109 POST-EXECUTION APPROVAL The signatures below indicate approval of this executed protocol by Inno Pharma. Name Signature Company Date

Release Date – 06 Mar 2012 Page 46 of 47 PharmaReady Version 5.0 Performance Qualification – DMS Admin 110 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: Date:

Reviewed By: Date:

Release Date – 06 Mar 2012 Page 47 of 47