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)

اطلع على كل الأخبار اطلع على كل الأخبار