SOP for Software Validation Activities in the Analytical Method Development Laboratory
| Department | Analytical Method Development |
|---|---|
| SOP No. | SOP/AMD/034/2025 |
| Supersedes | SOP/AMD/034/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 19/05/2025 |
| Effective Date | 20/05/2025 |
| Review Date | 19/05/2026 |
1. Purpose
This SOP describes the validation process for all software systems and computerized instruments used in the Analytical Method Development (AMD) laboratory to ensure 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
- Follow the V-model of validation per GAMP 5 and FDA 21 CFR Part 11.
- Phases include:
- User Requirement Specification (URS)
- Functional Specification (FS)
- Design Specification (DS)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Maintain records using Annexure-1: Software Validation Master Checklist.
5.2 User Requirement Specification (URS)
- Define specific needs of the AMD lab such as:
- Peak integration and reporting
- Audit trails and access control
- Data export and backup
- Document in Annexure-2: URS Template and approve by QA and Head – AMD.
5.3 Qualification Activities (IQ/OQ/PQ)
- IQ: Verify installation of software, license keys, operating environment.
- OQ: Execute predefined test scripts to confirm:
- User roles and permission matrix
- System settings, report formats
- Electronic signature and audit trail
- PQ: Real-time tests using dummy data and simulated workflows from the AMD environment.
- Document using Annexure-3: IQ Report, Annexure-4: OQ Report, and Annexure-5: PQ Report.
5.4 Data Integrity & Security Controls
- Ensure compliance with ALCOA+ principles:
- System must maintain unalterable audit trail
- Access must be password protected
- Only authorized users can create or delete data
- QA to review and sign off Annexure-6: Data Integrity Compliance Checklist.
5.5 Change Management and Periodic Review
- All software updates must follow formal change control per SOP/QMS/045/2025.
- Periodic review of software validation to be performed annually or post-upgrade.
- 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
- Software Validation Master Checklist – Annexure-1
- User Requirement Specification Template – Annexure-2
- IQ Report – Annexure-3
- OQ Report – Annexure-4
- PQ Report – Annexure-5
- Data Integrity Compliance Checklist – Annexure-6
- 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 |