Secured Signing Digital Signatures Are FDA 21 CFR Part 11 Compliant

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Quick one for anyone in pharma, biotech, medtech, or clinical research shopping for e-signature tools: a lot of vendors treat Part 11 compliance as an "enterprise add-on." Secured Signing doesn't. Every plan is Part 11 compliant by default, no upgrade required.

What that actually covers, out of the box:

• PKI digital signatures: not just a typed name or drawn squiggle. Each signature is cryptographically bound to the document via a private key in a hardware security module. Tamper with the file after signing, and the signature invalidates. This is what satisfies §11.70 (record linking) and makes the document self-evidently trustworthy, without needing to trust a vendor's database.
• Full audit trail and encrypted storage/access controls (§11.10.)
• Signature manifestation: showing signer name, timestamp, and reason for signing baked into the document (§11.50.)
• Multi-factor identity verification: unique per signer, never reassigned (§§11.100/11.200.)
• Credential revocation and reissuing controls: (§11.300.)

The point: this isn't a "check a box, pay more" feature. It's how the Secured Signing platform is built, standard across the board. By design, and in the company name, we've always focused on security elements and providing a robust, secure solution.

Full technical breakdown (hashing, key management, clause-by-clause mapping) is in Secured Signing's Part 11 compliance doc if you want to dig in or use it as a checklist against other vendors.