AI validation quick reference
One question, one page. These cards come from the reference set behind Validating AI in GxP, built to be printed and pulled out mid-meeting rather than read cover to cover. Two of them are below in full, free, nothing to sign.
QR-11 · Medical device AI, mapped against SaMD
Use this card when your AI sits close to a device and two regulatory worlds meet. It sets GMP AI against Software as a Medical Device across six dimensions: regulatory anchor, performance standard, change control, labelling, audit and post-market. A pharma firm whose AI qualifies as SaMD carries both sets of obligations, and they are complementary rather than redundant. The card also covers the FDA's Predetermined Change Control Plan, the mechanism that lets an AI or ML SaMD be retrained inside a validated envelope without triggering a new 510(k).
QR-12 · The CDMO and CMO snapshot
Use this card when the AI you depend on runs inside somebody else's quality system. Contract manufacture splits the validation duty without splitting the accountability, so the evidence has to travel and the quality agreement has to say who produces what. The card sets out where the obligation sits, what to ask for before you sign, and what an inspector will expect to see when the model that affected your batch belongs to your partner.
Questions people ask
What is a quick reference guide for AI validation?
A quick reference guide is a single printable page that answers one validation question without the surrounding text. It carries the decision, the criteria and the evidence expected, so a quality or validation lead can use it during a meeting or an inspection rather than reading a chapter first.
How do you validate AI that runs at a CDMO or CMO?
Contract manufacture splits the validation work but not the accountability. The marketing authorisation holder stays answerable for the model that affected the batch, so the quality agreement must name who produces which evidence, and that evidence has to be available to your inspector, not just to your partner's.
Does AI in pharma need SaMD approval as well as GMP validation?
Only where the AI meets the definition of Software as a Medical Device. Where it does, the two obligations are complementary rather than redundant: one validation file can serve both purposes if it addresses both regulatory anchors, but a separate device regulatory file is still required.
How many quick reference guides come with the book?
Eleven, in Appendix E of Validating AI in GxP, covering tier decisions, evidence packs, test data, metrics, drift response, inspection readiness and generative AI. Buyers also receive five further cards beyond the two published here, and a free updated edition when EU GMP Annex 22 is finalised.