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Unitronics Automation

Simplifying FDA 21 CFR Part 11 Compliance

By February 7, 2025March 14th, 2025No Comments

Unitronics has always been compliant with the FDA CFR 21 regulations, ensuring secure electronic records and signatures. Now, we’re taking it a step further by simplifying compliance with added features that make implementation easier than ever!

Audit Trails – Automatically track and store user actions and system configuration changes without any programming, ensuring compliance and traceability.


Record Storage – UniCloud’s Backup and Restore feature ensures secure storage of records and machine configurations, preventing logs being lost in the event of external storage issues.

If you work in an industry that handles electronic records and signatures, these enhancements are essential for ensuring compliance:

  • Pharmaceuticals & Life Sciences
  • Medical Devices
  • Food & Beverage
  • Cosmetics
  • Biotechnology

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