The briefings

Everything published so far, newest first. Each piece is written to be useful on its own; no series homework required.

CSV/Jun 2, 2026/8 min

CSA is not the end of CSV. It is CSV finally done right.

FDA's Computer Software Assurance guidance was read by half the industry as permission to stop validating. The other half read it correctly.

CSV/May 21, 2026/7 min

The GAMP 5 software categories, explained like a human

Category 3, 4 or 5 decides how much validation work you are signing up for. Here is how to call it correctly, with a tool that does the asking.

Data Integrity/May 12, 2026/6 min

ALCOA+ in practice: nine words your records have to live up to

Attributable, legible, contemporaneous and friends. What the acronym actually demands once you leave the training slide.

GxP/Apr 28, 2026/7 min

Audit trail review without tears

Regulators expect you to review audit trails. Nobody tells you which ones, how often, or how to do it without losing your mind. Let us fix that.

Regulatory/Apr 14, 2026/6 min

Part 11 myths that refuse to die

Twenty-five years of 21 CFR Part 11, and the folklore is still winning. Test yourself against the eight claims we hear most.

AI/Mar 30, 2026/8 min

How do you validate a system that keeps learning?

Classic validation freezes a system and proves it. Machine learning models change with data. Something has to give, and the industry is deciding what.