Which technical requirements are there in 21 CFR Part 11 for an IT system?

Rating: +0

Positive Negative

• Unique identification of all users in the system. Each user needs his/her own account and password to log in
• Automatic audit trail created for all entries and changes of data in the system
• Audit trail includes date, time and ID
• Old versions of data are never overwritten, but given an "old" status
• How valid electronic signatures are created
• Procedural requirements include
• Validation of the system
• Large number of topics to be included in SOPs
• Proof that the SOPs are used accordingly