Topic
GAMP categories, risk-based testing, CSA, and how to validate without drowning in paper.
CSV/Jun 2, 2026/8 min
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
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.