Notes on integrity systems, timestamped evidence, and the products built on top of them.

21 CFR Part 11 Needs Independent Data Integrity

21 CFR Part 11 does not, by itself, guarantee independently verifiable data integrity. Modern integrity infrastructure can make record tampering and deletion detectable without relying on closed-system vendor trust.

Queryable Integrity Is a Product Shape

When integrity systems can be checked quickly enough to fit into ordinary product flows, they stop being back-office evidence and start becoming part of the interface.