Security

The I/A Series Batch Suite makes it easy to comply fully with FDA 21 CFR Part 11 Regulation for Electronic Records and Electronic Signatures.

It provides these features:

  • Each user can have a unique two-part electronic signature.
  • Each user is assigned a security level.
  • Password aging and reuse capability is provided.
  • Security can be assigned to specific actions. For example, users can be allowed to work only on recipes they have been trained to work on.
  • Actions are linked to signatures in the electronic record.
  • Electronic records are held in a secure repository.
  • Electronic records are accessible only to authorized parties.