Practical Guide to CSV: How to Implement the V-Model Without Getting Lost in Documentation

Validating a computerized system can seem like a daunting task. The secret is to follow a structured method—the famous V-Model—which links every specification phase to its corresponding verification phase. Here is an operational roadmap to complete a robust and audit-ready validation.

Phase 1: Planning and Risk Assessment

Everything starts with the Validation Plan. Define who does what (IT, QA, Business Owner) and what needs to be validated.

• GxP Assessment: Does the system impact patient safety or product quality? If yes, validation is required.
• Risk Assessment: Identify critical functions (e.g., yield calculation, electronic signatures). You will focus your most rigorous testing here.

Phase 2: Specifications (URS and FS)

You cannot test if you don't know what you want.

• User Requirements Specification (URS): Write SMART requirements (Specific, Measurable, etc.). You must include Data Integrity requirements (audit trail, backups) and security (password policy).
• Functional Specification (FS): Describes how the system meets the requirements. For commercial software (COTS), this often coincides with the technical manual or configuration document.

Phase 3: Testing (IQ, OQ, PQ)

Here the "V" goes back up. Each test verifies a specification.

• IQ (Installation Qualification): Is the system installed correctly? Verify hardware, software versions, and—crucially—that the environment is secure (physical/logical access).
• OQ (Operational Qualification): Does it function as intended? Test critical functions, edge cases (e.g., entering letters in a numeric field), and error handling. Tip: Verify the Audit Trail here!
• PQ (Performance Qualification): Does it work in the live process? This is the "acid test" with trained users and complete workflows (User Acceptance Test).

⚠️ Watch Out For... The Traceability Matrix

This is the tool that saves your life during an inspection. A matrix that links: URS Requirement -> Functional Specification -> Test Case -> Result Without this, you cannot prove that you have tested everything you requested.

Common Errors and Solutions

• Error: Testing only the "Happy Path."
• Solution: Include negative testing. What happens if the network fails? If the user enters the wrong password 3 times?
• Error: Not documenting test deviations.
• Solution: If a test fails, open a deviation, investigate the root cause, fix it, and repeat the test, documenting everything.

Quick Operational Checklist

• [ ] Validation Plan approved before testing begins.
• [ ] URS with explicit Data Integrity requirements.
• [ ] Risk Assessment completed to define the testing strategy.
• [ ] IQ/OQ/PQ executed with evidence (screenshots, logs).
• [ ] Traceability Matrix compiled.
• [ ] Final Validation Report signed, releasing the system.

Dive deeper with the complete guide on GuideGxP.com to access Validation Plan templates and Test Protocols.