PharmaReady Version 5.0
Performance Qualification – DMS Workflow
/ PharmaReady Version 5.0DMS Workflow
Performance Qualification
Complete Installation
Software Release Date – 06May 2012
Document Number: OQ83
Doc Version 1.0May 21, 2012
Company Name: ______
Address: ______
______
______
Project Name: ______
Server Name: ______
Server Location: ______
PQ 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-PQ Approval from Customer 5
6. PQ Roles and Responsibilities 5
7. Execution/ReviewSignature Verification 6
8. Create DocumentNumber Qualification 7
9. Create Document Template Qualification 9
10. CreateDocument From Template Qualification 11
11. CreateDocument Qualification 12
12. EditDocument Qualification 18
13. Review Document Qualification 22
14. Approve Document Qualification 25
15. Publish Document Qualification 28
16. Distribute Document Qualification 31
17. Read Document Qualification 32
18. Archive Documents Qualification 34
19. Post-Execution Approval 36
20. Protocol Deviation Report 37
Objective
This protocol outlines the requirements for the Performance Qualification (PQ) of the DMS workflow functions of the PharmaReady Document Management System 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 Performance 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 5.0
Procedure
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
· The DMS Admin Performance Qualification has successfully passed executions.
· 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.
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-Workflow”.
· 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 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.
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.
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.
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 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 PQ 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:Baskar Balaji, Implementation Engineer / Date / Vijay Srinivasan,
Sr. Manager / Date / QA Person / Date
This page is intentionally left blank.
Revision History
Version / Date / Author / Remarks1.0 / 21May 2012 / Baskar Balaji / Initial finalized version.
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 / DatePQ Roles and Responsibilities
Indicate each person’s responsibility in the Performance qualification protocol process. This should be filled before the PQ can be executed.
Name / Title / Role (Tester, Verifier, Reviewer, Approver)Execution/ReviewSignature 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 / AffiliationCreate DocumentNumber Qualification
Instructions: Qualify the basic Performance 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 /8.1a Logon to PharmaReady using these credentials:
· Logon ID: PQUser1
· Password: password
Expected Result:
My Preferences page displays for entry of a new password
8.1b On the My Preferences page, enter a new password for
the logged in account by entering the following
fields.
· Current Password: password
· New Password: password1
· Confirm New Password: password1
Also, change the date setting to match the global date setting which is dd/mmm/yyyy
Click the Submit button.
Expected Result:
The User password is changed, the My Preferences page
closes and the PharmaReady Home page displays.
8.2 Click on DMS Button and From the DMS menu, click the Doc Numbers sub-menu item to access the Doc Number Manager page.
Click the Add a New Doc Number button.
Expected Result:
The Add a New Doc Number page displays.
8.3 Define a new Doc Number by entering the following data in the associated fields.
· Category: Checklists
· Number:CHK-101
· Title: PQChecklist Document
· Owner: PQ User 1
· Status: Issued
· Superceded by: blank
Click the Submit button.
Expected Result:
The Doc Number Manager page displays. CHK-101 is listed with a status of Issued.
TAKE SCREEN SHOT
Comments:
Section Reviewed By: / Date:
Create Document Template Qualification
Instructions: Qualify the basic Performance 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 /While logged in as PQ User 1, from the DMS menu, click the Doc Templates sub-menu item to access the Doc Template Manager page.
Click the Add a New Document Template button.
Expected Result:
The Add a New Doc Template page displays.
Define a new Document Template by entering the following data in the associated fields.
· Library: QualityAssurance
· Title: PQTest Document Template
· Classification: PQTesting
· Uploaded File: blank
Click the Browse button. Double-click any MS Word document to be uploaded as a template. Ensure that the filename of the file added does not contain any special characters such as /, <, >, *, ^, \, etc...
Expected Result:
The file path appears in the Template File field.
TAKE SCREEN SHOT
Click the Submit button.
Expected Result:
The Doc Template Manager page displays with the newly added Document template in the list.
TAKE SCREEN SHOT
Click the PQ Test Document Template hyperlink in the Title column to view the uploaded document.
Expected Result:
The document displays in MS Word or a separate browser window.
Click the New Doc icon.
Expected Result:
The Create Document page opens with the “PQ Test Document Template” pre-populated in the Template field.
Comments:
Section Reviewed By: / Date:
CreateDocument From Template Qualification
Instructions: Qualify the basic Performance 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 /While on the Create Document page, enter the following data in the associated fields.
· Library: QualityAssurance (pre-populated)
· Category: Checklists
· Doc Number: CHK-101
· Doc Prop Template: QA - Doc Prop Template
· Initial owner: PQ User 1
· Initial Author: PQ User 1
· Template: pre-populated with PQ Test Document Template
Click the Submit button.
Expected Result:
The Document Properties page appears and is populated with data from the Doc Prop Template.
On the bottom of the Document Properties page, click the Cancel button.
Expected Result:
The Document Properties page closes and the Work with Documents page appears with the PQTestTemp01 document appearing.
TAKE SCREEN SHOT
Comments:
Section Reviewed By: / Date:
CreateDocument Qualification
Instructions: Qualify the basic Performance 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 of the active account and logon to PharmaReady using these credentials:
· Logon ID: PQUser2
· Password: password
Expected Result:
The PharmaReady Home page displays
11.1b Once logged in, On the My Preferences page, enter a new password for the logged in account by entering the following fields.
· Current Password: password
· New Password: password1
· Confirm New Password: password1
Also, change the date setting to match the global date setting which is dd/mmm/yyyy
Click the Submit button.
Expected Result:
The PharmaReady Home page displays
Click on DMS button to access PharmaReady DMS Home page. From the DMS menu, click the Create Document sub-menu item to access the Create Document page.
Expected Result:
The Create Document page displays.
Create a new Document by entering the following data in the associated fields on the Create Document page.
NOTE: The Upload File field is selected by clicking the Browse button and choosing the previously stored Document or typing the file path.
· Library:QualityAssurance
· Category: Checklists
· Doc Number: <Category Auto Number>
· Doc Prop Template: QA - Doc Prop Template
· Initial owner: PQ User 1
· Initial Author: PQ User 1
· Virtual Document Checkbox: blank
· Template: leave as <choose a Template>
· Upload File: Click the Browse button and select any relevant document. Ensure that the uploaded file name does not contain any special characters such as /, <, >, *, ^, \, etc...
TAKE SCREEN SHOT OF CREATE DOC PAGE
Click the Submit button.
Expected Result:
The Document Properties page displays with CHKL-1001 in the Document Number field.
TAKE SCREEN SHOT OF DOC PROPERTIES PAGE
Verify that PQ User 1 has received two New Document Notification e-mails for the following document numbers:
· CHK-101
· CHKL-1001
The email text will be similar to:
PQ User 1:
Document Number: “CHK-101”
Titled:“PQTestDocument1”
CHK-101has been added to PharmaReady and you are assigned as an Author for the document. Click the link below to open this document.
Expected Result:
PQ User 1 has received the notification e-mails.
TAKE SCREEN SHOT OR ATTACH EMAILS
Log off the active account. Logon to PharmaReady using these credentials:
· Logon ID: PQ User 1
· Password: password1
Expected Result:
PQ User 1 is logged in and the PharmaReady Central page displays.
Click on DMS Button to access PharmaReady DMS Home page, From the DMS menu, click the Work with Docs sub-menu item to access the Work with Documents page, and then click the Properties icon for the document CHK-101.
Expected Result:
The Document Properties page displays with CHK-101in the Document Number field andPQTestDocument1 in the Title field. The Activity Mode is set to “Edit”.
On the Document Properties page, enter or verify pre-populated fields the following data in the associated fields.
General Info Tab
· New Version Number:1.0
· Document Template Used: PQ Test Document Template
· Title: PQ Test Document 1
· Description: Document for Workflow PQ testing
· Author(s): PQ User 1 (Read Only)
· Keywords: PQ Test Doc Prop Temp, PQ
· Virtual Document: blank
· Part of Virtual Document: blank
· Category: Checklists
· Library: QualityAssurance
· Activity Mode: Edit
Key Dates Tab
· Create Start Date: current date
· Create Stop Date: current date + 1
· Review Start Date: current date+2
· Review Stop Date: current date + 3
· Approve Start Date: current date + 4
· Approve Stop Date: current date + 5
· Publish Date:blank
· Training Start Date: current date
· Training Stop Date: current date + 10
· Effective Start Date: current date
· Effective Stop Date: one year from current date
· Distributed Start Date: current date + 7
· Date Due Review: current date + 300
· Retention Period: 1 Year from Effective Stop Date
· End of Retention: blank
Authors/Owners Tab
· Authors:PQ User 1
· Owners:PQ User 1
Reviewers Tab
· Basic Cycle: Sequential
· Document Reviewers: Blank
· Document Reviewers Group: QA-ReviewerGroup
· Extended Cycle: None
Approval Tab
· Basic Cycle: Parallel
· Document Approvers: Blank
· Document Approvers Group: QA-ApproverGroup
· Extended Cycle: None
·
Readers Tab
· Type:Reader Group
· Reader Name: QA-ReaderGroup
· View Document: checked
· Read Required: checked
· Verify Read Required: checked
· Assessment: blank
Other Properties Tab
· Reason for Doc Change: Updated PQ document information.
· Previous Doc Number: PQ-
· SOP Training Stop Date: today’s date
· Species: Mice
· Dept Category: Testing
Projects: DMS-PQ
· Cabinet: Cabinet 1
· Drawer: Drawer 2
· Shelf & Bin fields: blank
· Disk & Filename fields: blank
· Reel & Frames fields: blank
· Image ID: blank
· Site: File Room
E-Signature Information
· Meaning: Changed “other”
· Logon ID: Pre-populated with PQUser1
· Password: password1
TAKE SCREEN SHOT FOR EACH TAB
Click the Submit button.
Expected Result:
The Work with Documents page displays.
On the Work with Documents page, put a checkmark in the QV checkbox for CHK-101.
Open the Central Page.
Expected Result:
On the Work with Documents page the QV checkbox is checked. On the Central page, the document appears on the My DMS Quick View list.
TAKE SCREEN SHOT
Comments:
Section Reviewed By: / Date:
EditDocument Qualification