A Practical and Pragmatic Approach to Computer System Validation at Ab Biotechnology

At Ab Biotechnology, validation isn’t just about meeting regulatory requirements—it’s about ensuring our systems are efficient, reliable, and most importantly, help keep patients safe. We take a risk-based, practical approach to Computer System Validation (CSV) that balances compliance with real-world efficiency, always aligning with our Lean Six Sigma principles.

1. Understand the Regulatory Requirements

Before validation begins, we identify the relevant regulations and standards that apply to our systems—such as EU GMP Annex 11 and the FDA’s 21 CFR Part 11 for electronic records. These form the foundation of our validation approach and help us design a strategy that is both compliant and appropriate for our specific use cases.

2. Start with Risk

Every validation effort begins with a thorough risk assessment. Not all systems require the same level of validation—custom-built or high-impact systems demand more scrutiny, while low-risk, off-the-shelf solutions may require a lighter touch. We classify systems based on their potential impact on product quality, patient safety, and data integrity, ensuring our time and resources are focused where they matter most.

3. Make the Most of What’s Available

When working with commercial off-the-shelf software, we leverage supplier documentation, if it meets our internal standards, and execute in conjunction with in-house testing. This avoids unnecessary duplication and speeds up deployment while maintaining compliance.

4. Develop a Clear Validation Plan

A well-defined validation plan provides structure and accountability. It outlines:

• The scope of the system
• Roles and responsibilities
• Validation activities
• Acceptance criteria

This clarity helps keep the validation process organized, auditable, and aligned with both business objectives and compliance requirements.

5. Verify Requirements and Ensure Traceability

Clear, testable requirements are critical. We build traceability from user requirements through to testing, using well-designed test scripts to confirm that systems function as intended. Features such as audit trails, access controls, and data accuracy are not just checked—they’re tested to ensure they work in practice.

6. Build in Data Integrity from Day One

Data integrity isn’t an afterthought—it’s a fundamental part of our validation process from the very beginning. We follow guidance from MHRA, EU GMP Annex 11, to ensure systems are designed and validated with secure access, audit capabilities, and robust data handling.

7. Maintain Validation Through the System Lifecycle

Validation doesn’t end once the report is signed. Maintaining a system’s validated state requires ongoing change control, periodic reviews, and continuous monitoring. Whether due to a software update or a change in regulatory expectations, our lifecycle approach ensures our systems remain fit for purpose and compliant.

Our Philosophy

At Ab Biotechnology, we validate what matters, document what’s needed, and continuously seek improvement. Our CSV process is grounded in industry best practices but guided by a pragmatic mindset. 

Please get in contact if you would like to see how we can support your projects.
enquiries@abbiotechnology.com