FMS 5 is compliant environmental monitoring system software for the Pharmaceutical, Medical Device and Life Science industries. All software development activities at TSI follow the ISPE GAMP® lifecycle model. FMS 5 is assigned current GAMP® category 4 as configurable software. It is specifically intended for use where compliance to EU GMP Annex 1 and FDA cGMP aseptic processing guidance is required.
FMS 5 enables compliance to the FDA 21 CFR Part 11 ruling. Full audit trail, password aging and lockout after failed logins, ensures secure, tamper proof data archiving and reporting. System security is easily configurable. User groups allow users and managers appropriate levels of system access.