21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

1. User Management

   • Unique User ID and password for each user

   • Multiple user levels (Operator, Supervisor,  Admin)

2. Electronic Signatures

   • Secure electronic approval instead of handwritten signatures

   • Dual authentication for critical actions (e.g., login + password confirmation)

3. Audit Trail

   • Automatic recording of all system events and changes

   • Records user name, action performed, date and time

4. Access Control

   • Role-based permissions to restrict unauthorized access

   • Only authorized users can change parameters or recipes

5. Data Integrity Protection

   • Prevents unauthorized modification or deletion of records

   • Any change is logged in the audit trail

6. Time-Stamped Records

   • All system actions are automatically date and time stamped

7. Password Security

   • Password complexity rules

   • Password expiry and periodic change

   • Account lock after multiple failed login attempts

8. Secure Data Storage

   • Electronic records stored in secure and protected format

   • Protection against data loss or tampering

9. Data Backup & Retrieval

   • Backup and restore functionality for electronic records

   • Easy retrieval of historical data for regulatory inspection

10. Electronic Record Export

• Ability to export reports and logs for documentation and audits