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Go paperless for regulated operations.

DocuSign's Life Sciences Modules for 21 CFR Part 11
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Simplify compliance.

DocuSign offers modules to support your compliance with the electronic signature practices set forth in the U.S. Food and Drug Administration’s 21 CFR Part 11. Our core Part 11 module includes additional Part 11-specific functionality for authentication, reason for signature, and signature manifestation. These capabilities help you comply with regulations while using eSignature to make executing agreements faster, more cost-efficient, and more convenient for everyone involved. Our Life Sciences Modules also enable compliance with regional standards like Annex 11.

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Authenticate two ways

Require two-factor authentication to access and sign documents.
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Know who did what

View a detailed audit trail and Certificate of Completion for each transaction.
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Account-wide controls

Apply module settings to all envelopes sent from your account to enable consistent compliance.

FAQ

Frequently asked questions.

How is DocuSign used in Life Sciences?

Life Sciences organisations use the DocuSign Agreement Cloud to reduce time to market, simplify global collaboration, and improve the patient, physician, and employee experience. For details, see our Life Sciences page.

Where can I get the technical details of DocuSign's Part 11 support?

See the white paper Using DocuSign to Facilitate Compliance with 21 CFR Part 11.

Where can I get help for Part 11 validation?

Our partner USDM provides implementation and testing services that enable Life Sciences customers to validate their technology systems and processes for Part 11 compliance.

Learn more

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