eSignature — 21 CFR Part 11 Signing for Internal and External Signers
Signatures Your Signers Understand — and Inspectors Accept
Send documents for signature to colleagues and to people outside your company. Signers see exactly where their signature will land, choose how it looks, and everyone receives the sealed copy when it is complete.
Signing should not be the slowest step in the process
Regulatory documents routinely need signatures from people outside the company — consultants, investigators, partners — as well as from colleagues. Too often that means printing, scanning and emailing, or a separate signing tool with no connection to the document record.
DnXT eSignature keeps the signature with the controlled document, for internal and external signers alike.
Clear for signers, complete for the record
Internal and external signers
Colleagues sign inside DnXT. External signers receive a secure email link — no account needed.
See where it lands
Before signing, each signer sees the document with their own boxes filled in and highlighted, and other signers’ boxes marked but left empty.
Typed or drawn
Choose one of three typed styles or draw a signature with a mouse, finger or stylus. The signer can correct their title before signing.
Meaning and identity recorded
The legal name, the meaning of the signature and re-authentication at the moment of signing form the signature record, in line with 21 CFR Part 11.
Sealed and certified
When the last signer signs, the document is sealed and a certificate of completion lists each signature in the envelope.
Copy to every signer
Every signer receives the completed copy by email; external signers get a private, view-only link.
Frequently asked
Do external signers need a DnXT account?
No. They sign from a secure link sent by email.
What makes the signature Part 11 compliant?
The signature record carries the signer’s legal name, the date and time, the meaning of the signature and re-authentication at signing. The visual style a signer chooses is presentation; it does not replace that record.
Can a signer see the document before signing?
Yes. The signing page shows a preview with the signer’s own fields filled in and every other signer’s fields left empty.
Who receives the signed document?
Every signer in the envelope receives the sealed copy by email once the last signature is applied.
Take the printer out of the process.
See a document go from draft to sealed, with an external signer, in a single walkthrough.
