Reimagining compliance in Life Sciences

This whitepaper explores the strategic shift from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA) in the Life Sciences industry. As organizations increasingly adopt agile digital tools and AI-driven platforms, CSV’s documentation-heavy, waterfall-based approach has become a bottleneck to innovation and speed.

CSA, endorsed by the FDA’s 2022 draft guidance, offers a risk-based, value-driven alternative that emphasizes critical thinking, automation, and fit-for-purpose validation. The paper outlines the philosophical and practical differences between CSV and CSA, provides a roadmap for transition, and demonstrates CSA’s applicability across diverse systems, from preclinical R&D to AI in drug discovery.

It also maps CSA principles to Quality Management System (QMS) domains, showing how CSA enhances compliance, agility, and innovation without compromising patient safety or data integrity.

Key takeaways:

• CSV vs CSA – A Paradigm shift
• Why CSA is needed
• CSA principles
• CSA in practice
• Integration with QMS
• Transition roadmap
• Role of digital tools
• Strategic impact

Download the whitepaper now.