PharmaReady Version 5.0

Performance Qualification – TRMS Admin

/ PharmaReady Version 5.0
TRMS Administration Setup
Performance Qualification
Complete Installation
Software Release Date –6 Mar 2012
Document Number:PQ82
Doc Version 1.0, 6 Mar 2012

Company Name: ______

Address: ______

______

______

Project Name: ______

Server Name:______

Server Location:______

PQ Prepared By:

______

Name / Title / Representing

______

Signature / Date

TABLE OF CONTENTS

1.Objective......

2.Procedure......

2.1.Prerequisites......

2.2.Execution......

2.3.Protocol Completion......

2.4.Acceptance Criteria......

3.Document Control......

4.Revision History......

5.Pre-PQ Approval from Customer......

6.PQ Roles and Responsibilities......

7.Execution/Review Signature Verification......

8.TRMS System Settings Qualification......

9.TRMS People Administration Qualification......

10.TRMS Lookup Table Qualification......

11.TRMS Job Requirement Administration Qualification......

12.TRMS Job Code Administration Qualification......

13.TRMS Assessment Administration Qualification......

14.TRMS Specifications Administration Qualification......

15.TRMS Course Administration Qualification......

16.TRMS Event Administration Qualification......

17.TRMS Certifications Administration Qualification......

18.TRMS Updating People Account Qualification......

19.Post-Execution Approval......

20.Protocol Deviation Report......

1.Objective

This protocol outlines the requirements for the Performance Qualification (PQ) of the administrative setup functions of the PharmaReady Training Management System (TRMS) 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 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 5.0. 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

2.Procedure

2.1.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.

2.2.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:
  • Header contains:
  • Project Name:
  • Version#:
  • Test Case Name: TRMS
  • Each Picture in Screen Capture Document
  • Test Case Step # above or below picture
  • 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:
  • The protocol step is inaccurate.
  • The data is entered incorrectly.
  • 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.

2.3.Protocol Completion

  • After completing the execution of the PQ, TAKE Solutions will retain a photocopy of the completed PQ document and all supporting documentation for support purposes.
  • TAKE Solutions 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 TAKE Solutions will retain a photocopy of the original documents for future product support.

2.4.Acceptance Criteria

  • Criteria for accepting the Performance Qualification TRMS Admin phase as being complete are:
  • The PQ document has been executed and all screen captures are printed, labeled, initialed, and dated.
  • Any deviations encountered have a corresponding deviation report that is corrected or resolved.
  • The PQ document has been verified by a witness.
  • The PQ document has been reviewed by quality assurance or designee.
  • 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.

3.Document Control

Authored by: / Reviewed by: / Approved by:
Balasubramani Moorthy, Quality Analyst / Date
12 Jan 12 / Shobana Nagarajan, Sr. Quality Analyst / Date
13 Jan 12 / Vijay Srinivasan,Sr. Manager –Implementation Support / Date
18 Jan 12

4.Revision History

Version / Date / Author / Remarks
1.0 / 16 Nov 12 / Ashok J / Finalized the PQ as per the 5.0 changes

5.Pre-PQ Approval from Customer

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

Name/Title / Signature / Date

6.PQ Roles and Responsibilities

Indicate each person’s responsibility in the Performance 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 protocolmust sign and initial in the space provided below. This is for signature and initial verification.

Printed Name / Signature and Initials / Affiliation

8.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: ______

Operation / Are Observed Results As Expected? (Note Any Discrepancies) / Tested & Verified By/Date
8.1.At the Client workstation, logon on to PharmaReady using the default Administrative account with these credentials:
  • Logon ID: admin
  • Password: (password entered during IQ)
Expected Result:
The PharmaReadyHomepage displays.
8.2.Click the TRMS Button on the PharmaReady home page.
Expected Result:
The TRMS Home page displays.
8.3.From the Admin menu, click the System Settings sub menu item to access the System Settings page.
Expected Result:
The System Settingspage for TRMS displays.
8.4.Define the TRMS E-Signature fields by entering the following data in the TRMS E-Signature Settings fields.
Click the checkbox next to the Update TRMS History action.
Click the Add button.
Enter the following meanings:
  • Update TRMS History Meaning 1: Completed Assessment
  • Update TRMS History Meaning 2: Attended Training Event
  • Update TRMS History Meaning 3: Read Specification
Expected Result:
The TRMS E-signature meaning fields contain the required text.
8.5.Click the checkbox next to the Change TRMS Requirements action.
Click the Add button.
Enter the following meanings:
  • Change TRMS Requirements Meaning 1: Created New Job Requirement
  • Change TRMS Requirements Meaning 2: Updated Job Requirement
  • Change TRMS Requirements Meaning 3: Deleted Job Requirement
Expected Result:
The System Settings page displays with the newly added TRMS E-signature fields completed.
8.6.Click the checkbox next to the Change TRMS Courses action.
Click the Add button.
Enter the following meanings:
  • Change TRMS Courses Meaning 1: Created New Course
  • Change TRMSCourses Meaning 2: Updated Course
  • Change TRMS Courses Meaning 3: Deleted Course
TAKE SCREEN SHOT OF E-SIGNATURE SETTINGS
Click the Submitbutton.
Expected Result:
The System Settingscloses. The TRMS Home page appears.
8.7.Reopen the System Settings page and delete one of the e-sig meanings.
Click the Delete button next to Change TRMS Courses Meaning 3: Deleted Course
Click OK to confirm the deletion.
Click Submit.
Expected Result:
The 3rd e-sig meaning for Change TRMS Courses is deleted. The System Settingspage closes. The TRMS Home page appears.
8.8.Reopen the System Settings page
Verify the Change TRMS Courses Meaning 3: Deleted Course no longer appears.
Click Cancel.
Expected Result:
The System Settings closes. The TRMS Home page appears.
Comments:
Reviewed By: / Date:

8. 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: ______

Operation / Are Observed Results As Expected? (Note Any Discrepancies) / Tested & Verified By/Date
8.9.Navigate to PharmaReady Home page, 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.
8.10.Define a new Person manually by entering the following data in the associated fields and then clicking the Submit button.
  • Logon ID:PQTRMSAdmin
  • Active checkbox: checked
  • First Name:TRMSAdmin
  • Last Name:Test
  • Last Logon: blank
  • Unit: blank
  • Email: (or valid comp 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:TRMS
b)Library: [read only]
c)Department: Quality Assurance
d)Role Name: Training Administrator
  • Assigned Reader Groups:QA-Reader Group
  • Assigned Projects:DMS-PQ
  • Assigned Job Codes:blank
  • Assigned Job Requirements:blank
  • Password: password
  • Confirm Password: password
  • Locked checkbox: blank
  • Clear All Action Items checkbox: blank
  • Send DMS Email Notification checkbox: blank
  • Send TRMS Email Notification checkbox: blank
TAKE SCREEN SHOT
Expected Result:
The Admin People page displays with the newly added Person in the list.
8.11.On the Admin People page, click the Add a New Person button.
Expected Result:
The Add New People page displays.
8.12.Define a new Person manually by entering the following data in the associated fields and then clicking the Submit button.
  • Logon ID:PQTRMSSuper
  • Active checkbox: checked
  • First Name:TRMSSuper
  • Last Name:Test
  • Last Logon: blank
  • Unit: blank
  • Email: (or valid comp 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:TRMS
b)Library: [read only]
c)Department: Quality Assurance
d)Role Name: Training Supervisor
  • Assigned Reader Groups:QA-Reader Group
  • Assigned Projects:DMS-PQ
  • Assigned Job Codes:blank
  • Assigned Job Requirements:blank
  • Password: password
  • Confirm Password: password
  • Locked checkbox: blank
  • Clear All Action Items checkbox: blank
  • Send DMS Email Notification checkbox: blank
  • Send TRMS Email Notification checkbox: blank
TAKE SCREEN SHOT
Expected Result:
The Admin People page displays with the newly added Person in the list.
8.13.On the Admin People page, click the Add a New Person button.
Expected Result:
The Add New Person page displays.
8.14.Define a new Person manually by entering the following data in the associated fields and then clicking the Submit button.
  • Logon ID:PQTRMSTrainee
  • Active checkbox: checked
  • First Name:TRMSTrainee
  • Last Name:Test
  • Last Logon: blank
  • Unit: blank
  • Email: (or valid comp email)
  • Phone: blank
  • Phone 2: blank
  • AD Authenticate checkbox: blank
  • AD Domain: blank
  • In-place Editing: blank
  • Department:Quality Assurance
  • Supervisor:Test, TRMSSuper ( IMPORTANT!!)
  • Default Printer: blank
  • Add a New Role
a)Type:TRMS
b)Library: [read only]
c)Department: Quality Assurance
d)Role Name: Trainee
  • Assigned Reader Groups:QA-Reader Group
  • Assigned Projects:DMS-PQ
  • Assigned Job Codes:blank
  • Assigned Job Requirements:blank
  • Clear All Action Items checkbox: blank
  • Send DMS Email Notification checkbox: blank
  • Send TRMS Email Notification checkbox: blank
  • Locked checkbox: blank
  • Password: password
  • Confirm Password: password
TAKE SCREEN SHOT
Expected Result:
The Admin People page displays with the newly added Person in the list.
TAKE SCREEN SHOT
8.15.From the Reportsmenu, select the Audit Log Listingsub-menu item to access the Audit Log Listing Report.
Expected Result:
The Audit Log Listing Reports page displays.
8.16.Verify the audit log has records of all People that are created in the system by selecting the following data.
Select “Admin, Admin” in the Person drop down list.
Select “All Fields” in the Report type drop down list.
Select “All” in the Activity drop down list.
Click the View Reportbutton.
Type / Activity / Old Value / New Value / Logon ID / Date/ Time
User / Create / _ / New User: PQTRMSTrainee / admin, admin / <date & time of Logon>
User / Create / _ / New User: PQTRMSSuper / admin, admin / <date & time of Logon>
User / Create / _ / New User: PQTRMSAdmin / admin, admin / <date & time of Logon>
Expected Result:
The Audit Log Listing reportfilters the data and displays (at least) the above three records.
TAKE SCREEN SHOT
Comments:
Reviewed By: / Date:

9.TRMS Lookup Table 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: ______

Operation / Are Observed Results As Expected? (Note Any Discrepancies) / Tested & Verified By/Date
9.1.From the PharmaReady Home page, click the Adminmenu and select the Lookup Tables sub menu item to access the Admin Lookup Table page.
Expected Result:
The Admin Lookup Table page displays.
9.2.Verify the following Lookup Tables have the following data. Click in the Table Type drop down list to select the applicable table.
  • Credit Unit: CEU, Hours
  • Course Type: JCAHO, GMP, Safety, HR, HIPAA, Security, Policy, Reg. Comp.
  • Delivery Method: Self Paced, Classroom, Internet
  • TRMS Event Type: Training Course, Seminar, CBT
  • Certificate Status: Active, Inactive, Suspended, Revoked
  • Investigator Sites: [blank]
Expected Result:
The Admin Lookup Table page displays with the Table Type and Lookup Names containing the above data.
9.3.Select the TRMS Event Type in the drop down list box. Click the Add a New Lookup Name button.
Expected Result:
The Add New Lookup Entry page displays.
9.4.Click in the Name field and enter ”PQ_Webinar”. Leave the Display Order field set at the default value.
Click the Submit button.
Expected Result:
The Admin Lookup Table page displays with the newly added lookup entry PQ_Webinar appearing for the TRMS Event Type table.
9.5.In the Name column click on PQ_Webinar.
Expected Result:
The Maintain Lookup Entry page displays.
9.6.Click in the Display Order field change the value to 5.
Click the Submit button.
Expected Result:
The Admin Lookup Table page displays with the PQ_Webinar value appearing at the top of the list for the TRMS Event Type table.
TAKE SCREEN SHOT
Comments:
Reviewed By: / Date:

10.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: ______

Operation / Are Observed Results As Expected? (Note Any Discrepancies) / Tested & Verified By/Date
10.1.Log off. Logon on to PharmaReady using the TRMS Administrative account with these credentials:
  • Logon ID:PQTRMSAdmin
  • Password: password
When prompted to change the password on the My Preference page, enter the
Old Password: password
new password :newpassword
Confirm New Password : newpassword
Click the Submit button.
Expected Result:
The PharmaReadyHome page displays.
10.2.From the TRMS Home page, click the Admin menu and select the Job Requirements sub menu item to access the Admin Job Requirements page.
Click the Add a New Job Req button.
Expected Result:
The Add New Job Requirement page displays.
10.3.Define a new Job Requirement by entering the following data in the associated fields.
  • Job Req:PQTestJobReq (Auto Spec)
  • Description: Test Job Req for PQ Execution
  • Active: checked
  • Start Date: blank
  • Stop Date: blank
  • Renewal Required: checked
  • Renewal Freq. (days): 365
  • Last Renewal Date: today’s date
  • Next Renewal Date: today’s date + 1 year
  • Specifications: (Select CHKL-1001 Document)
Note: Ensure the Training Specification checkbox is enabled in Document properties page of this CHKL-1001 document in DMS Module.
  • Verify Read Required:unchecked
  • Assessment Required:unchecked
  • Training Courses: blank
  • Meaning: Created New Job Requirement
  • Password: newpassword
TAKE SCREEN SHOT
Click the Submit button.
Expected Result:
The Admin Job Requirement page displays with the newly added Job Requirement in the list.
10.4.From the Admin Job Requirements page, click the Add a New Job Req button.
Expected Result:
The Add New Job Requirement page displays.
10.5.Define a new Job Requirement by entering the following data in the associated fields.
  • Job Req:PQTestJobReq (Manual Spec)
  • Description: Test Job Req for PQ Execution
  • Active: checked
  • Start Date: blank
  • Stop Date: blank
  • Renewal Required: checked
  • Renewal Freq. Days: 365
  • Last Renewal Date: today’s date
  • Next Renewal Date: today’s date + 1 year
  • Specifications: blank
  • Verify Read Required:unchecked
  • Assessment Required:unchecked
  • Training Courses: blank
  • Meaning: Created New Job Requirement
  • Password: newpassword
TAKE SCREEN SHOT
Click the Submit button.
Expected Result:
The Admin Job Requirement page displays with the newly added Job Requirement in the list.
TAKE SCREEN SHOT
Comments:
Reviewed By: / Date:

11.TRMS Job Code Administration Qualification