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.

Joe

About Joe

Product Marketing Specialist at Invensys Eurotherm
This entry was posted in Data Acquisition, eurotherm, Eurotherm Products, recorder and tagged , , , , , , , , , , , , , , , , , . Bookmark the permalink.

Leave a Reply