user acceptance testing.

Regulatory Affairs Team: Ensures that the computerized systems meet all applicable regulatory requirements, including compliance with 21 CFR Part 11 and other relevant guidelines.

4. Accountability

The QA Manager is accountable for ensuring that all computerized systems are validated and operate within the specified requirements. The IT and System Owner teams are responsible for executing the technical and functional aspects of validation, while the Regulatory Affairs team ensures compliance with regulatory requirements.

5. Procedure

5.1 Validation Planning

1. Identify the computerized system that requires validation, including its intended use and critical functions (Annexure-1).
2. Develop a Validation Plan that includes the scope, resources, responsibilities, testing requirements, and timelines for the validation process (Annexure-2).
3. Ensure that the Validation Plan aligns with applicable regulatory requirements, such as 21 CFR Part 11 (Annexure-3).
4. Obtain approval from the QA Manager and relevant stakeholders before proceeding with the validation process.

5.2 System Installation Qualification (IQ)

1. Verify that the system has been properly installed according to the manufacturer’s specifications and the validation plan (Annexure-4).
2. Ensure that hardware, software, and network configurations are correctly set up and meet the requirements specified in the Validation Plan.
3. Document the installation process, including verification of the system’s components and configuration (Annexure-5).
4. Ensure that all relevant documentation (e.g., system manuals, configuration files, licenses) is available for review and storage.

5.3 Operational Qualification (OQ)

1. Test the system’s functionality to ensure that it operates according to its specifications under normal operating conditions (Annexure-6).
2. Verify that all critical features, such as data input, processing, output, and reporting, function as required.
3. Document the test results, including any deviations or non-conformities, and ensure corrective actions are taken as needed (Annexure-7).
4. Ensure that the system meets all internal and external quality and compliance requirements, such as data integrity, user access control, and audit trails.

5.4 Performance Qualification (PQ)

1. Verify that the system performs consistently and reliably over time under actual operational conditions (Annexure-8).
2. Test the system with real data to ensure that it produces accurate and reliable results that meet quality standards.
3. Ensure that the system meets all acceptance criteria outlined in the Validation Plan and that any deviations are addressed (Annexure-9).
4. Document the results of the performance qualification tests and retain them for future audits and inspections.

5.5 Documentation and Record Keeping

1. Ensure that all validation activities, including IQ, OQ, and PQ, are thoroughly documented and stored securely (Annexure-10).
2. Maintain all validation records for a minimum of 5 years or as required by regulatory authorities.
3. Ensure that all records are accessible for audits and inspections by regulatory agencies (Annexure-11).

5.6 Change Control and Revalidation

1. Any changes made to the computerized system (e.g., upgrades, patches, configuration changes) must be evaluated for potential impact on system validation (Annexure-12).
2. If significant changes are made, the system must undergo revalidation to ensure that it continues to meet its specifications and compliance requirements.
3. Document all changes and revalidation activities in the Change Control Log (Annexure-13).

5.7 Ongoing System Monitoring

1. Monitor the performance of the computerized system during its lifecycle to ensure that it continues to meet functional and regulatory requirements (Annexure-14).
2. Conduct regular system audits and review user access logs to ensure data integrity, security, and compliance with applicable regulations (Annexure-15).
3. Address any issues identified during ongoing monitoring and update the system as necessary to maintain compliance.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• OQ: Operational Qualification
• PQ: Performance Qualification
• IQ: Installation Qualification
• GMP: Good Manufacturing Practice
• 21 CFR Part 11: FDA Regulations for Electronic Records and Signatures

7. Documents

1. Validation Plan (Annexure-1)
2. System Installation Checklist (Annexure-2)
3. System Validation Report (Annexure-3)
4. Installation Qualification Test Results (Annexure-4)
5. Operational Qualification Test Plan (Annexure-5)
6. Operational Qualification Test Results (Annexure-6)
7. Performance Qualification Test Plan (Annexure-7)
8. Performance Qualification Test Results (Annexure-8)
9. System Documentation Log (Annexure-9)
10. Change Control Log (Annexure-10)
11. Revalidation Documentation (Annexure-11)
12. System Monitoring Log (Annexure-12)

8. References

• 21 CFR Part 11 – Electronic Records and Electronic Signatures (FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Validation Plan

System	Intended Use	Validation Scope	Validation Methodology
LIMS	Laboratory Data Management	IQ, OQ, PQ	Vendor and internal testing

Annexure-2: System Installation Checklist

Component	Specification	Pass/Fail
Software Installation	Correct version and configuration	Pass

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP creation	New process	QA Head
01/02/2025	2.0	Updated validation steps to include ongoing monitoring	Process improvement	QA Head