Product Launch: 21CFRpart11 for SM450e


The Cerulean 21CFR PART 11 software upgrade for SM450e is available for customers wishing to comply with 21CFR Part 11 directive - Code of Federal Regulations, title 21.
The directive governs food and drug products within the US for the FDA and other agencies.

The software upgrade has a particular focus on electronic records and signatures and offers the following features and benefits:

  • Audit trails: Computer hardware and software that meets regulatory requirements as set in:
  • Electronic signature: Password-protected access for all user groups: Supervisor, Operator, Owner IT, Servicing
  • Versioning: Secure record of actions, for example, newly created, modified, maintained, archived, retrieved, or transmitted.
  • User Authentication: Any person carrying out actions is recorded to allow full traceability of who did what and when.
  • Login controls: Tamper secure records cannot be manipulated at a later date.
  • Data security: The package ensures:
    • Properly functioning and well-documented instruments
    • Validation of functions relating to data integrity, security and traceability

Order 21CFRpart11 for your SM450e by quoting stock code 98402 (windows 10 version)

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