Metasys for Validated Environments (MVE) - Metasys - LIT-12011832 - General System Information - Metasys System

Metasys for Validated Environments (MVE) - Metasys - LIT-12011832 - General System Information - Metasys System - 13.0.50

Metasys System Configuration Guide

Product name

Metasys System

Document type

Configuration Guide

Document number

LIT-12011832

Version

13.0.50

Revision date

2024-07-17

Product status

Active

Metasys for Validated Environments (MVE) is a feature designed for facilities that require regulatory compliance for their environmental systems. MVE software is installed on a Metasys ADX, which provides the ability to configure supervisory engines as validated devices. The following table lists the current upgradeable Release 10.1, Release 11.0, Release 12.0 and Release 13.0.1 validated engines.

Table 1. MVE validated engines
Release 10.1	Release 11.0	Release 12.0	Release 13.0.1
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-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-SNC25150-0 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-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-SNC16120-0 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	M4-SNC16120-04 M4-SNC16121-04 M4-SNC16122-04

Important: All validated engines must be at the same major and minor release as the MVE Site Director. For example, if the MVE Site Director is at Release 13.0.50, the major and minor release is 13.0, all validated engines must be at Release 13.0.1. However, you can have non-validated engines at a previous release (12.0 or earlier). Refer to Metasys for Validated Environments on Site Management Portal Catalog (LIT-1900466) and Metasys for Validated Environments on Metasys UI Catalog Page (LIT-1901214) for further information about validated engines.

MVE is only supported on an ADX. MVE is available at Release 12.0.50 and Release 13.0.50 as MVE on Metasys UI and MVE on SMP UI. MVE is not available at Release 13.0.

Note: From Release 13.0, SNx engines include Metasys UI only. For the manual process needed to use SMP UI to directly access SNx engines, see Launcher. User actions on alarms and audits are limited when you use Metasys UI to directly log on to a validated engine. For more information, refer to Metasys for Validated Environments on Metasys UI Technical Bulletin, (LIT-12014262).

MVE is specifically designed to help customers address United States Food and Drug Administration (FDA) 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] 2021).

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.