eSigning and Compliance

Don't just design good processes-make sure they are followed.

Maintain compliance with regulations using the M-Files eSigning & Compliance extension.

M-Files eSigning & Compliance Extension

If you need reliable eSignatures and process control capabilities, as well as data processing system compliance with standards and regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11, the M-Files eSigning & Compliance extension is for you.

Pharmaceutical, medical device manufacturing, biotechnology, biologics and other highly-regulated industries have in-depth compliance requirements – meaning you need to stay on top of content management needs related to electronic records, signatures, electronic submissions and more.


With the M-Files eSigning & Compliance extension, you can maintain compliance with regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11 more easily than ever. These regulations apply to information technology and related systems used in connection with regulated activities, including process control, documentation and data processing systems. Additional benefits of the M-Files eSigning & Compliance extension include:

  • Electronic signing for all data object types in addition to documents, such as audit findings and CAPAs
  • Easy to configure and easy to use
  • Complies with known requirements
  • Excellent authorization control
  • Faster approvals with automatic display of content waiting for signature on users' task lists
  • Simple workflow approval
  • Leaves a time-stamped record in the audit trail
  • Efficient handling of multiple signatures with batch approvals

Plus, you can use the M-Files eSigning & Compliance extension in conjunction with your CRM or ERP system, making M-Files a central repository for all important company documents and information, ensuring important business content is managed and accessed in a unified and consistent manner.

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