Systec Autoclaves Give You Data Control and Documentation for FDA 21 CFR Part 11 Compliance

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Your advanced Systec autoclave stores cycle data that can be downloaded from the autoclave, or transferred directly to your network via FTP as PDF and/or CSV (Excel) files. Both documents are electronically signed by the autoclave. This electronic signature is unique and specific to each autoclave. Manual manipulation of any data will result in the file being marked as invalid.

The advanced 21 CFR Part 11 solution includes:

  • Extended user account control with customizable access, group assignments and more.
  • AuditTrail: all executed actions are documented and can be traced back to the respective user and time stamp.
  • There are up to five fields for electronic signatures.

Systec Connect Documentation System (DS)

All information on your Systec autoclave - at a glance. All information of a run is clearly displayed, and data can be tracked live at any time. Systec Connect DS serves purely as "read only" to observe all autoclaves connected to the network and ensure that all processes have run correctly. To ensure validity of the sterilization process, changes to the parameters or intervention of the processes are not possible.