The 21CFR Part 11 guidelines were defined in 1997 by Food and Drug Administration. These regulations mainly deal with the Electronic Records and Electronic Signature. This was a major step towards defining the equivalence of these records to the legacy Paper based records and handwritten signatures. Along with this guidelines, introduction of Information Technology (IT) in compliance was a milestone.
This regulation defines how paperless record systems compliant with the current good manufacturing practice under which they will be considered equivalent to conventional paper records & handwritten signatures.
The system construction by the user must be based on the following points to comply HMI Platform with the FDA 21 CFR Part 11 regulations.
- User Management Functionalities:
- Password protected individual Unique user account.
- Password Complexity.
- Minimum 8 Character password length.
- Configurable Number of Wrong Attempt
- User Block/Unblock Facility
- Password Validity.
- Multiple User Level as per the User Rights
- Audit Trail:
- Tamperproof and Non-Editable Audit Trail Data Format.
- The time stamp of the change of the parameter value and user making the change
- The audit trail records following details-
- User Creation
- User Login/ Logout
- Wrong attempts of login
- User Block / Unblock by Administrator
- Old value and new value of parameter change
- The time stamp of each event
- System Data and Data Backup:
- HMI offers basic connectivity for data exchange with Central SCADA / MES / ERP by following means-
- Through OPC UA
- Through Data file transfer
- Through USB / SD Card Backup
- Electronic Data Record and Data storage:
- Review of the reports on the HMI Screen for Production, Alarms and Audit Trail.
- Storage limit can be interlocked in terms of the number of batches produced or % of the memory consumed.
- Report Generation and Printing:
- Batch data is stored in secured database format and Batch Report can be generated using this data.
- Report Printing: The report printing has been offered in multiple ways-
- Online printing of Alarms, Events and Logged data through Serial Printer
- Printing of General report through USB and Network Printing