Electronic Records; Electronic Signatures
Part 11 sets criteria under which FDA considers electronic records and signatures trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
What the authority record establishes
Part 11 sets criteria under which FDA considers electronic records and signatures trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
Binding when applicable together with the governing predicate rules
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
Laboratory buyers need to connect system features to the actual electronic records, signatures, controls, and predicate-rule obligations in scope rather than treating a product label as a compliance conclusion.
Affected operating stages
- Record Identification
- System Controls
- Signature Controls
- Retention
- Inspection
Capabilities to examine
Electronic Signatures Audit Trails And Record History
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 electronic signatures audit trails and record history.
Role Identity Access And Segregation-Of-Duties Controls
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 role identity access and segregation-of-duties controls.
Deployment Administration Change Control And 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 deployment administration change control and validation support.
Affected buyer audiences
- quality units
- laboratory leaders
- validation teams
- technology owners
- auditors
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
The regulation does not approve, certify, validate, or determine the suitability of a laboratory product or configuration.