Metasys for Validated Environments (MVE) is an enhanced feature of the Metasys system that audits user management for critical environments to facilitate U.S. Food and Drug Administration (FDA) electronic records and signature requirements (Title 21 Code of Federal Regulation [CFR] Part 11). MVE is also compliant with other similar agencies around the world that deal with electronic records and electronic signature requirements, such as Annex 11 of the European Union Good Manufacturing Practice (EU GMP) regulations (European Medicines Agency [EMEA] 1998).
MVE provides secure data management and reporting capabilities, traceable electronic records and signatures, and time-stamped audit trails for facilities subject to Part 11 compliance. Any action or change initiated by the user on a validated device, such as alarm acknowledgment or setpoint adjustment, requires user reauthentication and electronic signature with required annotation.
MVE can be used only on an ADX running Metasys system supported server-based operating systems. The ADX software, MVE software, and network engines at the MVE site must each be at the same Metasys release level (Release 10.1). MVE supports access by Active Directory service users of the Metasys system from the standard login screen. SSO access is not supported because SSO is disabled for MVE installed on an ADX.
For more information, refer to the Metasys for Validated Environments, Extended Architecture Technical Bulletin (LIT-12011327).