Spectra Manager™ CFR provides secure access and features compliant with 21 CFR Part 11; system access requires a user name and password which are assigned by the Workgroup Manager and individual Access Levels determine the access to Administrative Tools which includes instrument configuration, analysis applications, user setup, workgroup setup and security policies as well as system and application history logs. Three levels of electronic signatures are required including creation, review, and approval stages. An audit trail is recorded in each data file recording any data processing performed on the spectral data.
● Management of security information for systems, users, data and records
● Access control for secure systems by user ID and password
● Audit trail function with time-stamp for tracking records
● Three levels of electronic signatures for record integrity