Regulatory

21 CFR Part 11 in Russian practice

Electronic records and electronic signatures — and what that means for an EDC.

What Part 11 requires

Part 11 of Title 21 of the US Code of Federal Regulations sets requirements for electronic records and electronic signatures: authenticity and integrity of records, an inseparable link between signature and record, an audit trail.

Why it matters in Russia

If study data may end up in an FDA dossier, electronic records and signatures must meet Part 11 no matter where the study runs. International projects with Russian sites live under both canons at once — the EAEU Rules and Part 11.

How the core is designed for it

Re-authentication on every signature, recorded meaning and scope, a hash of the data snapshot, automatic invalidation of the signature when covered data is edited — it cannot be switched off. The audit trail is unconditional and immutable.

The claim level

We say “designed for the requirements” — conformance for your processes is confirmed by the customer's own validation. The “invariant → test” traceability matrix and process descriptions are available on request.

Signing a form electronically in X7 Insight: meaning, scope and re-authentication — Electronic signature of a form: meaning, scope, data snapshot.

Next — in the documentation: Electronic signaturesAudit trail

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