Metasys for Validated Environments (MVE) - Metasys - LIT-12011279 - General System Information - Metasys System - 13.0

Network and IT Guidance Technical Bulletin

Product name
Metasys System
Document type
Technical Bulletin
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Revision date
Product status

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] 2021).

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 validated network engines at the MVE site must each be at the same Metasys release level, for example, Release 12.0.

Note: At Metasys Release 12.0.50, the ADX and MVE software must be at 12.0.50 and the validated engines at 12.0.

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.

Note: To use SQL Server 2019 with Metasys products, you must install Microsoft cumulative update package 3 (KB2984923) for SQL Server 2019. To download the update package, visit
Note: Use SQL Server 2016 or 2017 for Metasys Advanced Reporting System (MARS). MARS does not work with SQL Server 2019.

For more information, refer to the Metasys for Validated Environments on Site Management Portal Technical Bulletin (LIT-12011327) or Metasys for Validated Environments on Metasys UI Technical Bulletin (LIT-12014262).