Metasys for Validated Environments (MVE), extended architecture is a feature designed for facilities that require regulatory compliance for their environmental systems. MVE software is installed on Metasys ADX, which provides the ability to configure supervisory engines as validated devices. The following table lists the existing upgradeable MVE Release 10.1 and 11.0 validated engines and the Release 12.0 MVE supported validated engines:
| Release 10.1 | Release 11.0 | Release 12.0 |
|---|---|---|
| MS-NAE5510-2 | MS-NAE5510-2 | — |
| MS-NAE5510-3 | MS-NAE5510-3 | MS-NAE5510-3 |
| M4-SNE22000-0 |
M4-SNE22000-0 M4-SNE22001-0 M4-SNE22002-0 |
M4-SNE22000-0 M4-SNE22001-0 M4-SNE22002-0 |
| M4-SNC25150-0 |
M4-SNC25150-0 M4-SNC25151-0 M4-SNC25152-0 |
M4-SNC25150-0 M4-SNC25151-0 M4-SNC25152-0 |
| M4-SNC25150-04 |
M4-SNC25150-04 M4-SNC25151-04 M4-SNC25152-04 |
M4-SNC25150-04 M4-SNC25151-04 M4-SNC25152-04 |
| M4-SNC16120-0 |
M4-SNC16120-0 M4-SNC16121-0 M4-SNC16122-0 |
M4-SNC16120-0 M4-SNC16121-0 M4-SNC16122-0 |
| M4-SNC16120-04 |
M4-SNC16120-04 M4-SNC16121-04 M4-SNC16122-04 |
M4-SNC16120-04 M4-SNC16121-04 M4-SNC16122-04 |
All validated engines have to be at the same release as the validated site director. For example, if the validated engines are at 12.0, the validated Site Director also needs to be at 12.0. However, you can have non-validated engines at a previous release (11.0 or earlier). Refer to Metasys for Validated Environments, Extended Architecture Catalog Page (LIT-1900466) for further information about validated engines.
MVE is not supported on an OAS and it is not supported on Metasys UI.
MVE is specifically designed to help customers address United States Food and Drug Administration (USFDA) Title 21, Code of Federal Regulation (CFR) Part 11 compliance. 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).
The ADX with MVE software provides secure data management and reporting capabilities, traceable electronic records and signatures, and time-stamped audit trails for facilities subject to Part 11 compliance. It manages and protects the long-term storage of trend data, audit data, event/alarm messages, annotations, and system configuration data. In addition, complex passwords and message encryption secure the system from unauthorized access and data tampering.