> ## Documentation Index
> Fetch the complete documentation index at: https://help.dsalta.com/llms.txt
> Use this file to discover all available pages before exploring further.

# 21 CFR Part 11

> Meet FDA requirements for electronic records and electronic signatures.

> 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.

<Note>
  Part 11 applies to FDA-regulated industries — pharmaceuticals, biotech, medical devices, and life sciences — that maintain records electronically.
</Note>

## Who needs 21 CFR Part 11?

<CardGroup cols={2}>
  <Card title="Life sciences companies" icon="flask">
    Pharmaceutical, biotech, and medical device companies subject to FDA oversight.
  </Card>

  <Card title="Clinical and lab systems" icon="microscope">
    Organizations using electronic systems for regulated records and signatures.
  </Card>
</CardGroup>

## Key components

<CardGroup cols={3}>
  <Card title="Validation" icon="circle-check">
    Systems must be validated to ensure accuracy, reliability, and consistent performance.
  </Card>

  <Card title="Audit trails" icon="timeline">
    Secure, computer-generated, time-stamped audit trails of record changes.
  </Card>

  <Card title="Electronic signatures" icon="signature">
    Controls ensuring e-signatures are unique, verifiable, and linked to records.
  </Card>

  <Card title="Access controls" icon="key">
    Limit system access to authorized individuals.
  </Card>
</CardGroup>

## How DSALTA helps with 21 CFR Part 11

<Steps>
  <Step title="Activate 21 CFR Part 11">
    Select 21 CFR Part 11 from the Frameworks page. DSALTA maps requirements to controls.
  </Step>

  <Step title="Review e-records controls">
    Review validation, audit trail, and e-signature controls.
  </Step>

  <Step title="Collect evidence automatically">
    Connect integrations to gather access and audit evidence.
  </Step>

  <Step title="Approve SOPs">
    Review and approve standard operating procedures for electronic records.
  </Step>

  <Step title="Prepare for inspection">
    Organize validation and audit trail evidence for FDA inspection.
  </Step>
</Steps>

## Frequently asked questions

<AccordionGroup>
  <Accordion title="Does Part 11 require system validation?" icon="circle-check">
    Yes. Systems managing regulated electronic records must be validated to demonstrate they perform reliably and accurately.
  </Accordion>

  <Accordion title="What are the e-signature requirements?" icon="signature">
    Electronic signatures must be unique to one individual, verifiable, and permanently linked to their records.
  </Accordion>
</AccordionGroup>

## Related pages

* [Active Frameworks](/guides/compliance/frameworks-active)
* [Available Frameworks](/guides/compliance/frameworks-available)
* [Controls](/guides/compliance/controls)
* [Audits](/guides/compliance/audits)