Data integrity through tamper-proof measurement databases with audit trail
The additional function Audit-Trail/FDA provides functions for the software ProfiSignal Basic or Klicks for the validation of monitoring applications according to the guidelines of FDA 21 CFR Part 11.
ProfiSignal projects are protected by the user management. Different authorisation levels can be assigned with a username and password entry. These range from simple observer to operator to administrator. Of course, individual operating functions can also be enabled or disabled for each user.
The audit trail logs user interventions depending on the user management, both in the case of configuration changes of the hardware as well as software changes and the actuation of operating elements on the PC. In case of project/software changes, the automatic versioning system is activated so that all documents are automatically available for validation.
Product highlights
- User management with different authorisation levels
- Integrated alarm management with rights-dependent provision of alarm lists and alarm acknowledgement
- Redundant tamper-proof measurement data archiving on a measurement data server and directly in the acquisition hardware
- Logging of user interventions depending on the user management, both in case of configuration changes of the hardware as well as in case of software changes and the operating elements on the PC (audit trail)
- Regular automatic report generation on recorded measurement data, alarm events that have occurred and user interventions that have been carried out