The standards we build to.
Each framework below is operationalised in the platform, not just referenced. The detailed evidence - validation plans, risk assessments, traceability - is shared under MNDA.
Category 3/4/5 lifecycle
Risk-based validation depth driven by GAMP 5 categorisation. The platform itself is validated as a Category 4 baseline.
Computerised systems
Validation, data storage, audit trails, and electronic signatures addressed clause by clause in a private-tenant deployment.
Records & signatures
Electronic signatures, computer-generated audit trails, and protected record retention per sub-parts B and C.
Data integrity
Every record checked against the nine ALCOA+ criteria on every cycle - attributable, legible, contemporaneous, and the rest.
Quality risk management
Critical-thinking documentation and formal, risk-based scoping baked into how the agent works.
AI governance
The model layer is governed under a documented regime aligned to EU AI Act Articles 12-13 and the NIST AI RMF.