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放射性薄层扫描仪安装确认方案

更新时间：2025-06-28      浏览次数：27

 

 

放射性薄层扫描仪安装确认方案

编码：QSTWS-JSVP-IQ016

 

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北京华瑞森科技发展有限公司

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RaPET-Lab/B-AR-2000-1放射性薄层扫描仪系统的安装确认方案

RaPET-Lab/B-AR-2000-1 System

Installation Qualification (IQ) Protocol

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Document Review and Approval


Role

Name

Date

Signature

Reviewed By

System User




Reviewed By

Information Technology




Reviewed By

Quality Assurance




Approved By

System Owner




 

Meaning of Signatures

Reviewer signatures indicate that this document reflects the tasks and deliverables necessary for validation of the SYSTEM and that this document has been prepared in accordance with appropriate regulatory agency standards.  Approver signatures indicate that this document complies with policies and procedures necessary to maintain the validated state of the SYSTEM throughout its operational lifecycle.

 

Document Change Log

Version

Date

Performed By

Description

1.0

Last Signature Date of   this Document


Initial release.

 

Table of Contents

1.... Introduction............................................................. 5

1.1     Purpose and Scope.............................................................. 5

1.2     References...................................................................... 5

2.... Configuration Verification................................................ 6

2.1     Pre-requisite 1 – Test Accounts..................................................... 6

2.2     Pre-requisite 2 –Acquisition Workstation Hardware Verification........................... 8

2.3     Pre-requisite 3 – Acquisition Workstation Software Verification........................... 9

3.... Installation Qualification Test Cases..................................... 10

3.1     Test Case 1 –Instrument Installation Qualification..................................... 10

3.2     Test Case 2 –Software Installation Qualification...................................... 11

3.3     Test Case 3 – Configure Software Security Settings................................... 16

Appendix A:  Post-Execution Summary........................................ 18

Appendix B: Discrepancy Log................................................. 19

Appendix C: Attachments.................................................... 20

Appendix D: Post-testing Approvals.......................................... 21

 

 

1         Introduction

1.1 Purpose and Scope

This document is the Installation Qualification (IQ) protocol for the RaPET-Lab/AR-2000 computerized system.

This document contains the test cases to be executed to ensure that the system is configured as specified in the User and Functional Requirements Specification and System Design and Configuration Specification.

Instructions for executing these test cases are found in the Validation Plan document.

1.2 References

·         RaPET-Lab/AR-2000  System Validation Plan, RaPET-Lab/AR-2000-VP

·         RaPET-Lab/AR-2000  System Validation Risk Assessment, RaPET-Lab/AR-2000-VRA

·         RaPET-Lab/AR-2000  System User and Functional Requirements Specification, RaPET-Lab/AR-2000-UFRS

·         RaPET-Lab/AR-2000 System System Design and Configuration Specification, RaPET-Lab/AR-2000-SDCS

·         RaPET-Lab/AR-2000 System Test Plan, RaPET-Lab/AR-2000-TP


  

2         Configuration Verification

2.1 Pre-requisite 1 – Test Accounts

Procedure:

Verify that each of the following test accounts has   been created and assigned to the specified user groups.  Record the username and password for each   account in the Username and Password columns, respectively.

SDCS Appendix D:

Category

Permission

(Group 1)
     Administrators

(Group 2)
     Scientist

(Group 3)
     Analyst

(Group 4)
     Reviewer

(Group 5)
     Engineer

(Group 6)
     OQ Operator

Administrative

Add Users

√

X

X

X

X

√

Create Users

√

X

X

X

X

√

Delete Groups

√

X

X

X

X

√

Edit Groups

√

X

X

X

X

√

Edit Users

√

X

X

X

X

√

Groups Admin

√

X

X

X

X

√

Remove Users

√

X

X

X

X

√

Super User

√

X

X

X

X

√

User Admin

√

X

X

X

X

√

Audit trail

Audit trail

√

√

√

√

√

√

Database

Restore Database

√

√

X

X

√

√

Evaluation

Evaluation Manager

√

√

X

X

√

√

Job

Review Job

√

√

√

√

√

√

Run Job

√

√

√

X

√

√

Report

Create Reports

√

√

X

X

√

√

Edit Reports

√

√

X

X

√

√

Hide Reports

√

√

X

X

√

√

Workflow

Create Workflows

√

√


X

√

√

Edit Workflows

√

√

X

X

√

√

Export Workflows

√

√

X

X

√

√

Hide Workflows

√

√

X

X

√

√

Import Workflows

√

√

X

X

√

√

Load Package

√

√

X

X

√

√

Load Workflows

√

√

√

X

√

√

 

Acceptance Criteria:

Each of the specified accounts have   been created and assigned to the specified user groups.

 

Group Type

Group Name

Pass /   Fail

Initials /   Date

Group 1

Administrators

Pass       Fail


Group 2

Scientist

Pass       Fail

Group 3

Analyst

Pass       Fail

Group 4

Reviewer

Pass       Fail

Group 5

Engineer

Pass       Fail

Group 6

OQ Operator

Pass       Fail

Comments:

Print   Tester Name:

 

Test   Performed By (Signature/Date):

 

Reviewer   Evaluation:

Did the script pass   or fail (circle one):       Pass   Fail

Reviewer   Signature/Date: 

 






           


 


   

2.2         Pre-requisite   2 –Acquisition Workstation Hardware Verification

Procedure:

Verify each of the following acquisition workstation   hardware specifications.  Record the   actual value in the “Actual" column.  Confirm that the actual value meets or   exceeds the expected value.

 

Acceptance Criteria:

The actual value meets or exceeds the expected value.

SDCS

Reference

Component

Specification

Pass /   Fail

Initials /   Date

Expected/Minimum

Actual


Model

See Actual

ThinkServer T100C

Pass   Fail



Computer Name

See Actual

INSTRUMENT-174

Pass   Fail


Serial Number

See Actual

GM0BZR06

Pass   Fail

A.1

Processor(s)

i5 or i7 processor (8th gen, 4 cores) or better

Intel Core i7-10700

Pass   Fail

A.2

Memory

8 GB

32   GB

Pass   Fail

A.3

Hard Drive

250GB

1TB

Pass   Fail

Comments:

Print   Tester Name:

 

Test   Performed By (Signature/Date):

 

Reviewer   Evaluation:

Did the script pass   or fail (circle one):       Pass   Fail

Reviewer   Signature/Date: 

 








 

 


   

2.3        Pre-requisite   3 – Acquisition Workstation Software Verification

Procedure:

Verify each of the following acquisition workstation   software specifications.  Record the   actual value in the “Actual" column.    Confirm that the actual value meets or exceeds the expected value.

 

Acceptance Criteria:

The actual value meets or exceeds the expected value.

SDCS

Reference

Component

Specification

Pass /   Fail

Initials /   Date

Expected

Actual

B.1

Operating System

Windows 10 64 bit


Pass /   Fail


B.2

Applications

RaPET-Lab v1.03.0010

RaPET-Lab v1.03.0010 

SCREEN CAPTURE

 

Pass /   Fail


B.3

Dongle

Software Dongle   is installed


Pass /   Fail


Comments:

Print   Tester Name:

 

Test   Performed By (Signature/Date):

 

Reviewer   Evaluation:

Did the script pass   or fail (circle one):       Pass   Fail

Reviewer   Signature/Date: 








 

3         Installation Qualification Test Cases


   

3.1 Test Case 1 –Instrument   Installation Qualification

Purpose of   Test:  Ensure that the AR-2000 Scanner instrument Installation Qualification is finished that the AR-2000 Scanner is installed without error.

Acceptance   Criteria:

The steps were executed successfully.

Step ID

Instruction

Expected Results

Actual Result

Initials /    Date

IQ-1.1               

Location / Environment

The files are   finished and reviewed.

Circle One:  Pass / Fail


IQ-1.2               

P-10   Gas Tank and Gas Connection

The files are   finished and reviewed.

Circle One:  Pass / Fail

IQ-1.3               

Computer Connection

The files are   finished and reviewed.

Circle One:  Pass / Fail

IQ-1.4               

Instrument and Options

The files are   finished and reviewed.

Circle One:  Pass / Fail

IQ-1.5               

Electrical Connections

The files are   finished and reviewed.

Circle One:  Pass / Fail

Print   Tester Name:

 

Test   Performed By (Signature/Date):

 

Reviewer   Evaluation:

Did the script pass   or fail (circle one):       Pass   Fail

Reviewer   Signature/Date: 

 







 

 


   

3.2 Test Case 2 –Software Installation Qualification

Purpose of   Test:  Ensure that the RaPET-Lab Software instrument Installation Qualification is finished that the RaPET-Lab Software is installed without error.

Acceptance   Criteria:

The steps were executed successfully.

Step ID

Instruction

Expected Results

Actual Result

Initials /    Date

IQ-2.1               

Running the Installer

On the   software USB stick, run the file “RaPET-Lab for AR2000 Build 1.03.0010 Setup" by   double-clicking on the filename.

You will   first see the following screen. Click “Next" to continue.

Circle   One:  Pass / Fail


IQ-2.2               

The software   will make sure you are ready to install it. Click “Install" when ready.

Circle   One:  Pass / Fail

IQ-2.3               

Several   boxes will appear on your screen showing progress of the installation. Some   of the boxes flash by quickly, others persist for some time. That’s normal.

Circle   One:  Pass / Fail

IQ-2.4               

At the end   of the installation you will be notified that it is completed. Click “Finish"   at this time to complete the software installation.

Circle   One:  Pass / Fail

IQ-2.5               

When Device Manager opens, go to the ports (COM & LPT) section and   click on the icon.

Circle   One:  Pass / Fail

IQ-2.6               

Find the communication port in Device   Manager dialog.

Circle   One:  Pass / Fail

IQ-2.7               

The active COM ports available will be presented. Note the one that   corresponds to the one you will be using for the AR-2000. RaPET-Lab/AR can   use any COM number but AR-Calib which can be used to help calibrate the   AR-2000 requires the COM port to be 1,2,3, or 4. It is best if you map the   comm port to 1 - 4.

COM port to be 1,2,3, or   4.

Circle One:  Pass / Fail

Print   Tester Name:

 

Test   Performed By (Signature/Date):

 

Reviewer   Evaluation:

Did the script pass   or fail (circle one):       Pass                Fail

Reviewer   Signature/Date: 

 







 

 


 
   

3.3 Test Case 3 – Configure Software Security Settings

Purpose of   Test:  Ensure that security   settings are properly configured.

Step ID

Instruction

Expected Results

Actual Result

Initials / Date

IQ-3.1               

Launch the RaPET-Lab Software.  Log in as an Admin(RL).

The RaPET-Lab Software opens.



IQ-3.2               

Open the Safety   Configuration dialog in the order of Administrator | User Administration |   Safety Configuration.

The Safety   Configurator dialog opens.

SCREEN CAPTURE

Circle One:  Pass / Fail


IQ-3.3               

Enforce screen lock: 15 min

SCREEN CAPTURE

Circle One:  Pass / Fail


IQ-3.4               

Lockout Attempts: 5

SCREEN CAPTURE

Circle One:  Pass / Fail


IQ-3.5               

Enforce password history: 4

SCREEN CAPTURE

Circle One:    Pass / Fail


IQ-3.6               

Password Expiration: 90 days

SCREEN CAPTURE

Circle One:    Pass / Fail


IQ-3.7               

Click the “Save &   Exit" button.




Print   Tester Name:

 

Test   Performed By (Signature/Date):

 

Reviewer   Evaluation:

Did the script pass   or fail (circle one):       Pass   Fail

Reviewer   Signature/Date: 

 







 

 

Appendix A:  Post-Execution Summary

Acceptance   Criteria:

Has   the test objective been met?

Yes         No

Have   ALL test steps Passed?  If No,   then refer to the discrepancies identified below.

Yes         No

Have   any unexpected results been resolved?

  N/A           Yes         No

Are   all applicable screen captures saved and attached to this protocol?

Yes         No

Are   all applicable printouts labeled appropriately and attached to this protocol?

Yes         No

Comments:








Performed by (sign/date):


Reviewed by (sign/date):

Appendix B: Discrepancy Log

Test Discrepancy Number

Description of Test Discrepancy

Date Opened

Date Resolved

Comments












































































 

Appendix C: Attachments

Attachment Number

Description

Number of Pages

Initials / Date

1.          

IQ Screen Captures



2.          




3.          




 

 

Appendix D: Post-testing Approvals

Post-testing Review and Approval


Role

Name

Date

Signature

Reviewed By

Quality   Assurance




Approved By

System   Owner




 

Meaning of Signatures

Reviewer signatures indicate that the reviewer has confirmed that the pre-requisites and test cases contained in this document have been executed fully, any discrepancies have been investigated and resolved, and all objective evidence has been attached to this protocol. Approver signatures indicate that this document complies with policies and procedures necessary to maintain the validated state of the SYSTEM throughout its operational lifecycle.