Need to meet 21CFR Part 11? Eurotherm has your solution!

What is 21CFR Part11?

Title 21: Part of the Code of Federal Regulations (CFR) that governs food and drugs within the US.

Part 11: The Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the US.

So what exactly makes a data recorder 21CFR Part11 compliant? Items such as:

  • Fully encrypted, unalterable data
  • Ability to print out identical records via Review software
  • Multiple archiving strategies provided (USB, FTP, Review, Compact Flash)
  • Individualized, unique user accounts and access levels
  • Full audit trail of any configuration changes printed to chart
  • Password expiration, enforce minimum PW length, change of PW upon initial login, etc.
  • Require digital signatures
  • Require authorizations

If you need data acquisition in any food & beverage or pharmaceutical application, the 6000 series data recorder / chart recorder from Eurotherm is exactly what you need!

More information on our graphical recorders can be found here.


About Joe

Product Marketing Specialist at Invensys Eurotherm
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