PharmaReady Version 5.1
Operational Qualification – DMS Workflow
/ PharmaReady™ Version 5.1DMS Workflow
Operational Qualification
Complete Installation
Software Release Date – 28 Jan 2013
Document Number: OQ63
Doc Version 1.0 28 Jan 2013
Company Name: ______
Address: ______
______
______
Project Name: ______
Server Name: ______
Server Location: ______
OQ Prepared By:
______
Name / Title / Representing
______
Signature / Date
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 4
4. Revision History 5
5. Pre-OQ Approval from Customer 5
6. OQ Roles and Responsibilities 5
7. Execution/Review Signature Verification 6
8. DMS Password Change Qualification 7
9. DMS User Logon Qualification 8
10. Create Document Number Qualification 14
11. Create Document Template Qualification 16
12. Create Document From Template Qualification 18
13. Create Document Qualification 19
14. Edit Document Qualification 29
15. In-Place Editing Document Qualification 36
16. Review Document Qualification 39
17. Approve Document Qualification 42
18. Publish Document Qualification 50
19. Distribute Document Qualification 54
20. Read Document Qualification 56
21. Adding User Distribution Qualification 58
22. Archive Documents Qualification 65
23. OQ Testing Data Deactivation (Optional) 68
24. Post-Execution Approval 71
25. Protocol Deviation Report 72
Objective
This protocol outlines the requirements for the Operational Qualification (OQ) of the DMS workflow functions of the PharmaReady Document Management System version 5.1. 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 DMS 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.
Procedure
Prerequisites
· All hardware, software, and infrastructure requirements must be completed.
· All Installation Qualifications protocols have successfully passed execution.
· The DMS Admin Operational Qualification has successfully passed executions.
· 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 pre-pended to all data values starting with “A” for the second execution, “B” for the third, etc.
Execution
· Print the Operational Qualification document.
· Execute the Operational 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, “DMS Screen Capture Document”.
· The “DMS Screen Capture Document” will be labeled with the following information:
o Header contains:
§ Project Name:
§ Version#:
§ Test Case Name: DMS
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
· 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.
o A screen shot was not taken for a required step.
· The Tester enters their initials and the date in the “Tested & Verified By/Date” 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 “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.
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 Operational 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 Operational Qualification DMS 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 DMS Admin OQ indicates that the criteria outlined in this protocol have been met and indicates acceptance of the system.
Document Control
Authored by: / Reviewed by: / Approved by:Ashok John,
Implementation Engineer / Date
24 Jan 13 / Hari Priya,
Quality Analyst / Date
25 Jan 13 / Vijay Srinivasan, Sr. Manager –Implementation Support / Date
28 Jan 13
Revision History
Version / Date / Author / Remarks1.0 / 24 Jan 2013 / Ashok John / Revised the OQ as per the 5.1 version
Pre-OQ Approval from Customer
The signatures below indicate approval of this OQ for execution by authorized customer staff.
Name/Title / Signature / DateOQ Roles and Responsibilities
Indicate each person’s responsibility in the operational qualification protocol process.
Name / Title / Role (Tester, Verifier, Reviewer, Approver)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 / AffiliationDMS Password Change 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: ______Date: ______
Verified by: ______Date: ______
Operation / Are Observed Results As Expected? (Note Any Discrepancies) / Tested & Verified By/Date /Logon on to PharmaReady using the OQ Test Admin account with these credentials:
· Logon ID: OQTestAdmin
· Password: password
Expected Result:
The My Preferences page displays for entry of a new password.
On the My Preferences page, enter a new password for the OQ Test Admin account by entering the following fields.
· Current Password: password
· New Password: password1
· Confirm New Password: password1
Click the Submit button.
Expected Result:
The User password is changed, the My Preferences page closes and the PharmaReady Home page displays.
TAKE SCREEN SHOT
Comments:
Section Reviewed By: / Date:
DMS User 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: ______Date: ______
Verified by: ______Date: ______
Operation / Are Observed Results As Expected? (Note Any Discrepancies) / Tested & Verified By/Date /Log off. Logon to PharmaReady using the test Library Admin account with these credentials:
· Logon ID: OQTestLibAdmin
· Password: password
Expected Result:
The My Preferences page displays for entry of a new password.
On the My Preferences page, enter a new password for the test Library Admin account by entering the following fields.
· Current Password: password
· New Password: password1
· Confirm New Password: password1
Click the Submit button.
Expected Result:
The User password is changed, the My Preferences page closes and the PharmaReady Home page displays.
Verify the Logon was captured in the Audit Log. From the Admin menu, click the Audit Log Viewer sub-menu item.
Expected Result:
The Audit Log Viewer opens and the Person field is defaulted to OQ Test Lib Admin.
Verify the following entries appear in the Audit Log Viewer.
Select User in the Type drop down list.
Click the Submit button.
Type / Activity / Old Value / New Value / Logon ID / Date Time
User / Logon / _ / _ / OQ Test Lib Admin / <date & time of Logon>
User / Property Change / Logon ID: OQ Test Lib Admin Password / Password / OQ Test Lib Admin / <date & time of password was changed>
User / Property Change / Logon ID: OQ Test Lib Admin PasswordStartDate / PasswordStartDate <date and time password changed> / OQ Test Lib Admin / <date & time of password start date>
Expected Result:
The Audit Log Viewer displays the correct entries for the OQ Test Lib Admin. . (NOTE: audit log may contain additional entries)
TAKE SCREEN SHOT
Log off. Attempt to logon to PharmaReady using the test Library Admin account with these credentials:
· Logon ID: OQTestLibAdmin
· Password: password
Click the Logon button.
Expected Result:
A red error message appears “The credentials provided are invalid.” OQTestLibAdmin is not logged on and the Logon page is still displayed.
TAKE SCREEN SHOT
Attempt the logon a second time, using these credentials:
· Logon ID: OQTestLibAdmin
· Password: oldpassword
Click the Logon button.
Expected Result:
A red error message appears again “The credentials provided are invalid.” OQTestLibAdmin is not logged on and the Logon page is still displayed.
Logon to PharmaReady using the test OQ Test Admin account with these credentials:
· Logon ID: OQTestAdmin
· Password: password1
Expected Result:
The PharmaReady Home page displays.
Under the Admin menu, open the People page, then open the Maintain People page for Test, OQLibAdmin and ensure the “Locked” checkbox is blank.
Expected Result:
The “Locked” checkbox is blank.
TAKE SCREEN SHOT
Log off. Attempt to logon to PharmaReady for the third time, using these credentials:
· Logon ID: OQTestLibAdmin
· Password: thirdtime
Expected Result:
A red error message appears. “The credentials provided are invalid.” OQTestLibAdmin is not logged on and the Logon page is still displayed.
Logon to PharmaReady using the test Admin account with these credentials:
· Logon ID: OQTestAdmin
· Password: password1
Under the Admin menu, open the People page, then open the Maintain People page for OQTestLibAdmin, and verify the “Locked” checkbox is checked.
Expected Result:
On the third failed logon attempt, the user’s account is locked. The “Locked” checkbox is checked.
TAKE SCREEN SHOT
Verify the Logon Attempt was captured in the Audit Log. On the Pharmaready Home page Click Admin menu, click the Audit Log Viewer sub-menu item. There will be 4 logon attempt entries.
Select User in the Type drop down list.
Select Logon Attempt in the Activity drop down list.
Select Test, LibAdmin in the Person drop down list.
Click the Submit button.
Type / Activity / Old Value / New Value / Logon ID / Date Time
User / Logon Attempt / _ / IP Address <number> / OQ Test Lib Admin / <date & time of Logon attempt>
User / Logon Attempt / _ / IP Address <number> / OQ Test Lib Admin / <date & time of Logon attempt>
User / Logon Attempt / _ / IP Address <number> / OQ Test Lib Admin / <date & time of Logon attempt>
Expected Result:
The Audit Log Viewer displays the correct entries for the OQ Test Lib Admin. . (NOTE: audit log may contain additional entries)
TAKE SCREEN SHOT
Logon to PharmaReady using the test Admin account with these credentials:
· Logon ID: OQTestAdmin
· Password: password1
On the Pharmaready home page, Under the Admin menu, open the People page, then open the Maintain People page for Test, LibAdmin.
Uncheck the “Locked” checkbox.
Click the Submit button.
Expected Result:
The “Locked” checkbox is cleared. The Maintain People page closes.
Verify that Invalid Logon Notify Email account listed on the System Settings- General page receives an e-mail notification about the locked account.
· Invalid Logon Notify ______
Expected Result:
The Invalid Log Notify Email account receives an e-mail with a message similar to: ”The account for user ID OQTestLibAdmin is locked.”
TAKE SCREEN SHOT OR ATTACH EMAIL
Log out. Attempt the logon again using these credentials:
· Logon ID: OQTestLibAdmin
· Password: password1
Expected Result:
OQTestLibAdmin is logged on and the PharmaReady Home page displays.
TAKE SCREEN SHOT
Comments:
Section Reviewed By: / Date:
Create Document Number Qualification