Operational Qualification - Admin

PharmaReady Version 6.0

Performance Qualification – TRMS Admin

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/Review Signature Verification 6

8. TRMS System Settings Qualification 7

9. TRMS People Administration Qualification 10

10. TRMS Job Requirement Administration Qualification 13

11. TRMS Job Code Administration Qualification 16

12. TRMS Assessment Administration Qualification 19

13. TRMS Specifications Administration Qualification 25

14. TRMS Course Administration Qualification 27

15. TRMS Event Administration Qualification 29

16. TRMS Updating People Account Qualification 31

17. Post-Execution Approval 33

18. Protocol Deviation Report 34

Objective

This protocol outlines the requirements for the Performance Qualification (PQ) of the administrative setup functions of the PharmaReady Training Management System (TRMS) version 6.0. 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 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 TRMS version 6.0. IQ’s and/or PQ’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.

·  The DMS Performance Qualification – Admin and Workflow have successfully passed execution.

·  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 “TRMS Screen Capture Document”.

·  The “TRMS Screen Capture Document” will be labeled with the following information:

o  Header contains:

§  Project Name:

§  Version#:

§  Test Case Name: TRMS

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 “TRMS 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 PQ 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 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, NAVITAS LLP will retain a photocopy of the completed PQ document and all supporting documentation for support purposes.

·  NAVITAS LLP will provide original executed PQ documents to the customer.

·  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.

·  A Validation Summary Report is prepared after execution of all applicable PQ protocols, summarizing the results. The customer will retain the completed original documents and all supporting documentation and NAVITAS LLP will retain a photocopy of the original documents for future product support.

Acceptance Criteria

·  Criteria for accepting the Performance Qualification TRMS 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.

o  The PQ document has been reviewed by quality assurance or designee.

o  The PQ 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 TRMS Admin PQ indicates that the criteria outlined in this protocol have been met and indicates acceptance of the system.

Document Control

Revision History

Pre-PQ Approval from Customer

The signatures below indicate approval of this PQ for execution by authorized customer staff.

PQ Roles and Responsibilities

Indicate each person’s responsibility in the Performance qualification protocol process.

Execution/Review Signature Verification

Instructions: All personnel (customer and NAVITAS LLP) assigned to execute, verify or review this protocol must sign and initial in the space provided below. This is for signature and initial verification.

TRMS System Settings Qualification

Instructions: Qualify the basic operation of critical administrative features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided.

Performed by: ______Date: ______

Verified by: ______Date: ______

TRMS People Administration Qualification

Instructions: Qualify the basic operation of critical administrative features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided.

Performed by: ______Date: ______

Verified by: ______Date: ______

TRMS Job Requirement Administration Qualification

Instructions: Qualify the basic operation of critical administrative features of the PharmaReady application as instructed below and note any discrepancies in the Comments space provided.

Performed by: ______Date: ______

Verified by: ______Date: ______

TRMS Job Code Administration Qualification