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.