The Essential CSV & Digitalization FAQ for Life Sciences Companies

At QbD Group, we’re asked about Computer Software Validation (CSV) every day by clients, partners, and industry stakeholders. From regulatory frameworks like GAMP 5 and 21 CFR Part 11 to the role of AI in validation — the landscape is complex, and the questions keep coming.

That’s why we’ve created this whitepaper: a practical FAQ guide based on real questions from the field. Whether you’re starting your validation journey or deep into maintaining compliance, this resource will help you stay informed, audit-ready, and confident in your software validation strategy.

Download now to get insights on:

• Key regulatory frameworks (GAMP 5, 21 CFR Part 11, Annex 11…)

• How to plan and implement CSV

• Ensuring operational compliance

• Leveraging digitalization and AI