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放射性薄層掃描儀安裝確認方案

更新時間：2025-06-28

瀏覽次數：126

放射性薄層掃描儀安裝確認方案

編碼：QSTWS-JSVP-IQ016

版本	編制	校核	CNPE審核	ZHQT審核	批準	發布日期
0	北京華瑞森科技發展有限公司	北京華瑞森科技發展有限公司	N/A	北京華瑞森科技發展有限公司

分發：

部門	數量	部門	數量	部門	數量
生產運行部	N/A	質量管理部	1	運營管理部	N/A
安全環保部	N/A	綜合管理部	N/A	工程部	N/A
EPC總包項目部	N/A

RaPET-Lab/B-AR-2000-1放射性薄層掃描儀系統的安裝確認方案

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	√	√	√	√	√	√
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.

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