Upgrade your CETI8 to conform to 21CFRpart11
The Cerulean’s 21CFRpart11 software upgrade for the CETI8 is now available for customers wishing to comply with 21CFRpart11 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.
Advantages and Features
• Electronic signature: Password protected access for all user groups: Supervisor, Operator, Owner IT, Servicing.
• User Authentication: Any one carrying out an action is recorded for full traceability of who did what and when.
• Login controls: Tamper secure records cannot be manipulated at a later date.
• Version controls: Secure record of actions, for example, newly created, modified, maintained, archived, retrieved, or transmitted.
• Data security: The package ensures:
• Validation of functions relating to data integrity, security, and traceability.
• Properly functioning and well-documented instruments.
• Audit trails: Computer hardware and software that meets regulatory requirements as set in LINK