Advanced Options
21 CFR Part 11 – Achieve compliance with U.C.ME-OPC™
U.C.ME-OPC™ supports FDA regulations, assisting pharmaceutical and food factories to achieve compliance with the following features:
- Electronic records of every operator action, signed with explanatory text and securely logged in a database.
- Password expiration and Minimum length.
- Confidentiality enforcement – only authorized users can add, edit or view data.
- User-specific inactivity time-out periods.
- Operators must provide an electronically signed explanation of their actions (system changes).
- Full accountability and traceability supported by automatic capture of who, what, when, and why-related information.
- Sort and filter by date/time, operator etc.
- Report export to HTML
Logging alarms and notification activity to an SQL database
U.C.ME-OPC™ logs all alarms, notification activity, acknowledgement received from the recipients to an SQL database (MS SQL Server and MS Access). The alarm history may be viewed and analyzed on any computer via Internet/Intranet using a web browser. This feature ensures a complete and thorough monitoring of every activity for enhanced efficiency and flexibility.





