Standard Operating Procedure (SOP)

1. Purpose

To define the process for validating software systems to ensure they meet their intended use, comply with regulatory requirements, and maintain data integrity and operational consistency.

2. Scope

This SOP applies to all new software systems, upgrades, configurations, and critical changes affecting regulated operations at [Company/Organization Name].

3. Responsibilities

• Validation Lead/Team: Plan, execute, and document software validation activities.

• System Owner: Ensure system requirements are defined and met.

• Quality Assurance (QA): Review and approve validation documentation and ensure compliance.

• IT Department: Support system setup, testing, and security.

• Users: Participate in testing (e.g., User Acceptance Testing) and report issues.

4. Definitions

• Software Validation: Establishing documented evidence that a software system meets its specified requirements and performs reliably.

• GxP Systems: Systems impacting Good Practice guidelines like GMP, GLP, GCP.

• 21 CFR Part 11: FDA regulation on electronic records and signatures (for pharma/regulated environments).

5. Procedure

5.1 Software Validation Planning

• Develop a Validation Plan covering:

  • Scope and purpose

  • Responsibilities

  • Risk Assessment

  • Validation deliverables and timelines

5.2 Risk Assessment

• Evaluate software impact on product quality, patient safety, and data integrity.

• Classify software as High, Medium, or Low risk.

5.3 Requirements Definition

• Gather and document:

  • User Requirements Specification (URS)

  • Functional Requirements Specification (FRS)

  • Design Specifications (DS)

5.4 Testing Activities

• Installation Qualification (IQ): Verify correct installation.

• Operational Qualification (OQ): Verify that the software functions according to specifications.

• Performance Qualification (PQ): Verify that the system performs as intended in the actual environment.

5.5 Documentation

• Develop and maintain:

  • Validation Plan

  • Test Protocols (IQ, OQ, PQ)

  • Test Cases and Test Scripts

  • Traceability Matrix (mapping requirements to tests)

  • Validation Summary Report

5.6 Change Control

• Manage and validate any post-implementation software changes through the Change Control process.

• Retest impacted functionalities (regression testing).

5.7 Final Approval

• Validation package reviewed and approved by QA and System Owner.

• Release software for operational use only after successful validation and approval.

6. Acceptance Criteria

• All critical requirements must pass testing without deviations.

• Deviations must be documented, evaluated, and resolved.

• Validation documentation must be complete, accurate, and audit-ready.

7. Documentation and Record Keeping

• Store validation documents securely and retain them for the required regulatory period.

• Ensure all signatures are captured appropriately (electronic or handwritten).

8. Compliance and References

• 21 CFR Part 11 (if applicable)

• GAMP 5 (Good Automated Manufacturing Practice)

• ISO 9001, ISO 13485 (for medical devices, if applicable)

• Company Quality Manual

9. Annexures

• Validation Plan Template

• Traceability Matrix Template

• Test Case Template

• Validation Summary Report Template

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