Regulatory Matrix

21 CFR Part 11 & Annex 11 Compliance Mapping

DigiVal is engineered to support the most rigorous audit standards in regulated sciences. The matrix below transparently presents requirement-control-evidence alignment.

Important Legal & Regulatory Notice:DigiVal software is designed to technically support FDA 21 CFR Part 11 and EU GMP Annex 11 compliance. Final regulatory validation remains dependent upon customer operational procedures within their Quality Management System (QMS).

Regulatory Section	Technical Control Mechanism	Audit Evidence Artifact	Shared Responsibility
FDA 21 CFR §11.10(a) System Validation	Installation (IQ), Operational (OQ), and Performance Qualification (PQ) packages provided.	Automated test verification reports and GAMP 5 compliant documentation.	Shared: DigiVal provides technical framework; customer validates according to internal SOPs.
FDA 21 CFR §11.10(b) Accurate Copies & Archiving	Export of all protocols and assessment reports in immutable PDF/A and raw JSON format.	Cryptographically signed SHA-256 verification export checksums.	Customer manages data archiving in accordance with corporate retention policies.
FDA 21 CFR §11.10(e) Timestamped Audit Trail	All record creation, modification, and revocation events logged with operator identities and timestamps.	Immutable sequential database and cryptographic hash ledger.	Managed automatically by DigiVal core services.
FDA 21 CFR §11.200 Electronic Signature Integrity	Two-factor authentication, signature intent binding (Author, Reviewer, Approver), and secure session tokens.	Unique signature certificates and non-repudiation audit logs.	Roles assigned and administered per customer authority matrix.
EU GMP Annex 11 (§9) Audit Trail Review	Critical process data and Out-of-Specification (OOS) parameter breaches are filterable.	OOS log queries and periodic audit trail export summaries.	Quality Assurance (QA) team conducts periodic independent reviews.

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