Every claim names its mechanism
Laboratories rarely sit under one regime, so the regulatory scope is deliberately broad — and stated in terms of what the platform actually does, not what it asserts. Fifteen frameworks are mapped to the mechanism that satisfies them.
Per-action signature policy from silent through required-with-second-factor to witnessed. Signing authority is re-established at the moment of signing and expires in five minutes.
Internal audit programme and management review built as first-class modules, with review inputs computed live from the operational tables and frozen on signed completion.
Audit findings carry TNI clause citations and open a linked CAPA in the same transaction. MDL and LOQ are computed against 40 CFR 136 Appendix B, and a study with fewer than seven replicates is labelled a preliminary estimate, not a validated one.
A per-tenant SHA-256 hash-forward chain over every significant event, with independent verification that reports exactly where a chain was broken.
Q1A(R2) through Q1E stability including photostability and ANCOVA poolability; Q2(R2) method validation; USP <71>, <85> and <788> modelled as workflow test nodes with their own acceptance criteria.
VMP, IQ, OQ and PQ artefacts, a functional requirements specification and an executed UAT record per module, and a workbook that traces requirement to test to evidence to release.
EPA methods under the Clean Water Act and Safe Drinking Water Act, statutory zone sampling under UK Schedule 3 and EU 2020/2184, and randomised sampling rounds that remain auditable.
40 CFR 160/792 study conduct and 21 CFR 210/211 manufacturing controls expressed as workflow gates, signature points and controlled documents rather than policy statements.
Bring your inspector's questions
Forty-five minutes, screen-shared, with the person who built it. Bring a real SOP or method and we will model it live.