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Meet FDA requirements for electronic records and electronic signatures.
21 CFR Part 11 is the US Food and Drug Administration (FDA) regulation governing electronic records and electronic signatures. It defines the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
Part 11 applies to FDA-regulated industries — pharmaceuticals, biotech, medical devices, and life sciences — that maintain records electronically.

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Who needs 21 CFR Part 11?

Life sciences companies

Pharmaceutical, biotech, and medical device companies subject to FDA oversight.

Clinical and lab systems

Organizations using electronic systems for regulated records and signatures.

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Key components

Validation

Systems must be validated to ensure accuracy, reliability, and consistent performance.

Audit trails

Secure, computer-generated, time-stamped audit trails of record changes.

Electronic signatures

Controls ensuring e-signatures are unique, verifiable, and linked to records.

Access controls

Limit system access to authorized individuals.

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How DSALTA helps with 21 CFR Part 11

1

Activate 21 CFR Part 11

Select 21 CFR Part 11 from the Frameworks page. DSALTA maps requirements to controls.
2

Review e-records controls

Review validation, audit trail, and e-signature controls.
3

Collect evidence automatically

Connect integrations to gather access and audit evidence.
4

Approve SOPs

Review and approve standard operating procedures for electronic records.
5

Prepare for inspection

Organize validation and audit trail evidence for FDA inspection.

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Frequently asked questions

Yes. Systems managing regulated electronic records must be validated to demonstrate they perform reliably and accurately.
Electronic signatures must be unique to one individual, verifiable, and permanently linked to their records.