Commands / kosa8 validate

kosa8 validate

Generate, sign and verify GxP qualification records (IQ, OQ)

Qualification evidence generated from the environment itself, for computerised-system validation under 21 CFR Part 11 and EU GMP Annex 11.

validate iq TARGET Installation Qualification of a sandbox or snapshot validate oq SNAPSHOT run a test protocol in a clone of a validated snapshot validate sign RECORD sign a record: executed, reviewed or approved validate verify RECORD check a record and its signatures offline

Each record is a signed package — record.json, RECORD.md, and the evidence each item rests on — that anyone can verify without kosa8 state or network. kosa8 generates evidence; it does not make anything validated. That is the regulated company's act, under its own quality system. See docs/design/gxp-validation.md.

Subcommands