The 21 CFR Part 11 guidelines were defined in 1997 by the Food and Drug Administration. These regulations mainly deal with Electronic Records and Electronic Signatures. This was a major step towards defining the equivalence of these records to the legacy paper-based records and handwritten signatures. Along with these guidelines, the introduction of Information Technology (IT) in compliance was a milestone.

This regulation defines how paperless record systems compliant with the current Good Manufacturing Practice (cGMP) will be considered equivalent to conventional paper records and handwritten signatures.

The system construction by the user must be based on the following points to comply with HMI Platform with the FDA 21 CFR Part 11 regulations.

1. User Management Functionalities:

• Password protected individual unique user account
• Password complexity
• Minimum 8 character password length
• Configurable number of wrong attempts
• User block / unblock facility
• Password validity
• Multiple user levels as per user rights

2. Audit Trail:

• Tamper-proof 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

3.HMI Connectivity:

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

4. 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 percentage of memory consumed

5. 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

6. Online Printing:

• Online printing of alarms, events, and logged data through serial printer

7. General Report Printing:

• Printing of general report through USB and network printing