Demystifying 21 CFR Part 11 for Software Quality in Healthcare, Pharma and related industries

How can healthcare companies ensure software quality and compliance to FDA 21 CFR Part 11?

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What is FDA CFR Part 11? How are healthcare, pharmaceuticals and related providers impacted by it? With organizations moving to a paperless state with advances in digital technology, electronic records and recordkeeping provide efficiency and organization.

But how do these companies ensure compliance? Especially with multi-stage validation, authentication and steps like signatures?

The FDA has set out the guidelines of 21 CFR Part 11 with the following goals:

  • To authenticate the validity of electronic records
  • To authenticate eSignatures and records
  • To validate the reliability of electronic records and electronic signatures

This comprehensive white paper talks in depth about the process of regulatory compliance using eSignature, audit trails, audit compliance reports, reauthentication and all the requisite protocol and processes. Find out more about the various use cases of QMetry Test Management’s eSignature that helps compliance-driven organizations in healthcare meet their mandate.

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