Products & Solutions

Part 11 Compliance

MVE
Since the advent of Part 11 in 1997, a Part 11 Specialty Team out of the Johnson Controls Life Sciences Division has monitored the evolution of the regulation and has analyzed its impact on the Life Sciences industry and specifically on facilities and facility related data. Consequently, the company has developed innovative programs and strategies to guide their Life Sciences clients through the planning, execution and maintenance of Part 11 compliance solutions for building management systems in a structured and cost-effective manner that reduces risk and cost.

The Johnson Controls approach to Part 11 compliance is comprehensive in that it addresses both the technological and procedural components involved in achieving compliance.

Technological:

Our industry-leading Metasys® building management system was enhanced to add the appropriate features to enable compliance. We call the system Metasys® for Validated Environments or MVE. The MVE system has been installed at over 100 pharmaceutical campuses around the world. An updated version, introduced at the 2007 Interphex Show, is a Web-based system that runs on standard IT networks.

Resources:

 
 
Press Release from Interphex Show 
DOC file iconDOC
MVE on MSEA Brochure 
PDF file iconPDF

Procedural:

The creation and execution of a qualification protocol and set of standard operating procedures that ensure the system achieves compliance and remains in that state during it life cycle.

A Note about Risk-based Regulation:

Since the FDA announced its intention to pursue a more risk-based approach to regulation, Johnson Controls has taken the lead in exploring the best approaches and the necessary steps that must be taken to assure safe and cost effective risk-based regulation. This area is still evolving, but our experts can help you analyze your risk and put together a sensible and defensible approach designed to satisfy the FDA’s requirements. Our experts have been featured in a number of articles on the topic and have been featured speakers on risk-based regulation at industry events. Read more about Risk-based Regulation by clicking on the link below: Articles and White papers
Part 11 Compliance
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