CSV to CSA: a practical guide for small biotech
What the FDA Computer Software Assurance guidance changes, what stays under Part 11, and how to update your validation SOPs.
GxP quality and validation blog
The Annex 11 revision and draft Annex 22: what they mean for your validated systems
A plain guide to the draft EU Annex 11 rewrite and the draft Annex 22 on AI in GxP, and how to prepare your validated systems.