Regulated by design
Each page below states the requirement, what the software does about it, what evidence that produces, and what stays with your organization. No certification is claimed — software is not compliant on its own, and the largest gap is stated first rather than buried.
Frameworks
What is recorded, how tampering is detected, and who can verify it independently.
Read coverageAudit trails, authority checks, signature manifestation and record linking, and re-authentication at signing.
Read coverageInvestigator oversight, ethics gating, risk-based monitoring, and controlled data changes.
Read coverageAttributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available.
Read coverageNo validation package is supplied. This is the largest gap, and it blocks regulated use until the customer closes it.
Read coverageOne set of technical controls, three regimes, and the obligations that stay with your organization.
Read coverageIdentity, authorization, tenant isolation, hardening, and what depends on how you deploy.
Read coverageRandomization and blinding, supply, medical coding, a safety gateway, a validation package and a log of who read what are absent. Everything else that is missing, in one place.
Read coverage