News & Knowledge Center

Articles, news, and knowledge on Computer System Validation, CQV, and AI/ML validation in GxP environments: EU Annex 22, data integrity, and audit readiness.

Articles and knowledge

• The ADC Boom Is Quietly a Swiss Manufacturing Story
• AI Governance in Pharma Has Two Layers. People Keep Confusing Them.
• Annex 22 Isn't About AI. It's About Risk.
• CDMO Capacity Is the Real Bottleneck in AI Drug Discovery
• Cleaning Validation Is Where Audits Actually Fail
• You Already Know CSV: It Is the CQV V-Model You Use Every Day
• Data Is King: ALCOA+ and What AI Does to Your Data Governance
• An FMEA Template for Validating an AI Tool in GMP
• From URS to IQ: How a Requirement Becomes a Test
• GAMP 5 in One Sentence: Category + Risk = Effort
• The Hard Part of AI in Pharma Is Getting It Through the Door
• Human-in-the-Loop Isn't a Limitation. It's a Compliance Feature.
• In Vivo CAR-T Could Strand the Cell Therapy Factories
• The Cheapest Qualification Is the One Your Supplier Already Did
• From Molecule to Medicine: A Plain-Language Primer on Life Sciences Manufacturing
• Phase-Appropriate GMP: What You Can Skip in Phase 1
• The Biggest Risk in AI-Assisted Validation Is Reviewer Complacency
• Single-Use Deleted a Cleaning Validation. It Created a Recycling Problem.
• Most Validation Protocols Are Written Backwards
• Where Does Your GMP Data Go? Ask Your AI Vendor.
• The System Is Qualified. But Who Qualified the Test?