Software Solutions & Services

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

 

The Essential CSV & Digitalization FAQ for Life Sciences Companies

 

Download now

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This resource is ideal for Quality Managers, IT leads, Regulatory Affairs professionals, and anyone involved in software used in GxP environments.