REGQUALITYREVIEW

Evidence for systems that carry regulated work.

United States · U.S. federal regulation

21 CFR Part 11 — Electronic Records; Electronic Signatures

Part 11 defines criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.

CurrentBinding where regulated records required by an FDA predicate rule are maintained or submitted electronically and Part 11 applies

What the authority record establishes

Part 11 defines criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.

Binding where regulated records required by an FDA predicate rule are maintained or submitted electronically and Part 11 applies

The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.

Why it matters to this market

Electronic quality and regulatory platforms frequently process predicate-rule records. Buyers must evaluate technical controls, procedural controls, intended use, record retention, audit trails, access, signatures, and system lifecycle together rather than accept a generic Part 11 badge.

Affected operating stages

  • Requirements And Intended Use
  • System Selection
  • Validation And Release
  • Electronic Record Creation And Approval
  • Access And Signature Administration
  • Audit-Trail Review
  • Retention, Export, And Retirement

Capabilities to examine

Controlled Documents

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for controlled documents.

Training Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for training management.

Quality Events And Deviations

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for quality events and deviations.

CAPA

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for CAPA.

Change Control

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for change control.

Audit And Inspection Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for audit and inspection management.

Computerized-System Validation Support

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for computerized-system validation support.

Regulatory Product And Registration Data

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for regulatory product and registration data.

Submission Planning And Dossier Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for submission planning and dossier management.

Health-Authority Correspondence

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for health-authority correspondence.

Affected buyer audiences

  • FDA-regulated pharmaceutical, biologic, and device organizations
  • quality and regulatory operations
  • information technology and security
  • computerized-system assurance and validation teams
  • records-management owners

Implementation questions

  • Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
  • What is binding, what is guidance, and what is a technical or consensus standard?
  • Which publication, adoption, effective, application, transition, and enforcement dates differ?
  • Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
  • How will a source revision affect open work and historical decisions?

Interpretation boundary

Part 11 does not approve software products or create a standalone certification. Applicability depends on the predicate record, intended use, and the regulated organization's technical and procedural controls.