Electronic Signatures for ISO 13485 and FDA 21 CFR Part 11 compliance


Streamline approvals and meet the regulation

For medical device developers, a compliant e-signature package should come as standard. You don’t need expensive biometric solutions to meet the regulation and you shouldn’t be paying extra for third-party integrations either.

Your e-Signature package should help you:

  • Prevent falsification of records
  • Show the ‘meaning’ of every signature on a document
  • Ensure full traceability of all decision making
  • Create a complete audit trail of changes and approvals

Don't just take our word for it.

How Cognidox helps

Cognidox’s e-Signature solution ensures:

  • You have complete control over the use of e-signatures in your system
  • e-Signatures are unique (cannot be shared or falsified)
  • e-Signatures are password protected (with passwords changed frequently)
  • Create a complete audit trail of approvals
  • Approvals can always be linked to a specific individual
  • e-Signatures are part of a complete audit trails
  • Documents show the printed name of the signatory
  • Documents show the date and time a signature was applied
  • Documents show the meaning of the approval - i.e. what the signatory intended
  • The signing event is added to the documents’ secure audit trail
  • The signature cannot be removed once it is applied

See Cognidox in action

Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.