Designed to assist compliance with 21 CFR Part 11 FDA guidelines on electronic records security and to prevent unauthorized access to the instrument, the SAE module can be enabled to support a single instrument or multiple units concurrently.
- Authenticate each user and verify their permission to perform controlled activities.
- Audit all data-impacting events for traceability on the instrument as well as in the Design and Analysis desktop software.
- Permits e-signature function for data verification