they are suitable for their intended use, comply with regulatory guidelines, and safeguard data integrity.

2. Scope

This SOP applies to all analytical software and computerized systems including HPLC, GC, UV-Vis spectrophotometer software (e.g., Empower, LabSolutions), LIMS systems, and standalone or network-based instruments used for method development activities within the AMD department.

3. Responsibilities

• IT/CSV Team: Leads software validation lifecycle activities, executes testing protocols, maintains audit trails.
• Analytical Scientist: Defines user requirements and provides functional input during validation phases.
• QA: Reviews validation documentation and authorizes system release for GMP use.
• Head – AMD: Approves User Requirement Specifications (URS), oversees validation readiness, and ensures training of users.

4. Accountability

The Head of AMD is accountable for ensuring that all analytical software used in the lab is validated before use and that periodic reviews are performed to maintain compliance.

5. Procedure

5.1 Software Validation Lifecycle

1. Follow the V-model of validation per GAMP 5 and FDA 21 CFR Part 11.
2. Phases include:
   • User Requirement Specification (URS)
   • Functional Specification (FS)
   • Design Specification (DS)
   • Installation Qualification (IQ)
   • Operational Qualification (OQ)
   • Performance Qualification (PQ)
3. Maintain records using Annexure-1: Software Validation Master Checklist.

5.2 User Requirement Specification (URS)

1. Define specific needs of the AMD lab such as:
   • Peak integration and reporting
   • Audit trails and access control
   • Data export and backup
2. Document in Annexure-2: URS Template and approve by QA and Head – AMD.

5.3 Qualification Activities (IQ/OQ/PQ)

1. IQ: Verify installation of software, license keys, operating environment.
2. OQ: Execute predefined test scripts to confirm:
   • User roles and permission matrix
   • System settings, report formats
   • Electronic signature and audit trail
3. PQ: Real-time tests using dummy data and simulated workflows from the AMD environment.
4. Document using Annexure-3: IQ Report, Annexure-4: OQ Report, and Annexure-5: PQ Report.

5.4 Data Integrity & Security Controls

1. Ensure compliance with ALCOA+ principles:
• System must maintain unalterable audit trail
• Access must be password protected
• Only authorized users can create or delete data
2. QA to review and sign off Annexure-6: Data Integrity Compliance Checklist.

5.5 Change Management and Periodic Review

1. All software updates must follow formal change control per SOP/QMS/045/2025.
2. Periodic review of software validation to be performed annually or post-upgrade.
3. Track revalidation activities using Annexure-7: Validation Review Log.

6. Abbreviations

• AMD: Analytical Method Development
• CSV: Computer System Validation
• IQ/OQ/PQ: Installation/Operational/Performance Qualification
• GAMP: Good Automated Manufacturing Practice
• LIMS: Laboratory Information Management System

7. Documents

1. Software Validation Master Checklist – Annexure-1
2. User Requirement Specification Template – Annexure-2
3. IQ Report – Annexure-3
4. OQ Report – Annexure-4
5. PQ Report – Annexure-5
6. Data Integrity Compliance Checklist – Annexure-6
7. Validation Review Log – Annexure-7

8. References

• GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
• 21 CFR Part 11 – Electronic Records; Electronic Signatures
• WHO TRS 1019 Annex 5 – Good Data and Record Management Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Software Validation Master Checklist

Phase	Status	Date	Remarks
URS	Completed	01/05/2025	Approved by QA
IQ	Completed	03/05/2025	Installation successful

Annexure-2: URS Template

Requirement	Description	Criticality
Audit Trail	Track all user actions	High
Data Backup	Automatic scheduled backups	Medium

Annexure-3: IQ Report

Item	Specification	Observed	Status
Operating System	Windows 10 Pro	Windows 10 Pro	Pass

Annexure-4: OQ Report

Test	Expected	Observed	Status
User Role Access	Analyst: No Delete	Correct	Pass

Annexure-5: PQ Report

Run No.	Sample	Result	Status
PQ-001	Standard Peak	Ret Time: 5.88 min	Pass

Annexure-6: Data Integrity Compliance Checklist

Parameter	Compliant	Remarks
Audit Trail Review Enabled	Yes	Real-time
Access Control	Yes	Password protected

Annexure-7: Validation Review Log

Review Date	System	Version	Action Taken
10/05/2025	Empower 3	Build 3471	Validated – No revalidation needed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Included PQ testing and GAMP 5 lifecycle model	Data integrity audit enhancement