MVE - Metasys for Validated Environments
MVE is an environmental control system for facilities that may be subject to FDA Title 21 CFR regulations and more specifically Part 11 electronic information management requirements. The system is a specialized application of the Metasys network that includes built-in features to facilitate Part 11 compliance.
The Validated Environments solution is a suite of services and technologies for facilities that may be subject to Food and Drug Administration (FDA) Title 21, Code of Federal Regulation (CFR) and more specifically the requirements of Part 11 electronic records/electronic signatures. From discovery through production, facility performance and regulatory compliance are critical elements to an effective operation. MJ Mechanical combines technology and procedure to build the right solution for all your critical environment demands. With the Validated Environments, end-to-end Part 11 compliance is easily realized and backed by the industry leader in creating and maintaining high-performance Building Automation Systems (BASs) worldwide.
Metasys® Building Automation and Control Systems
The Metasys® building management system ensures all of your building systems – comfort controls, lighting, fire safety, security and equipment – operate together in harmony. With its innovative, IT-based infrastructure, software and wireless capabilities, Metasys is the one building management system that coordinates and organizes all the information logically, then delivers it where and when you need it.
Metasys offers even more; more mobility, flexibility, reliability, visibility and more opportunities to create comfortable, safe and sustainable environments. Here’s how:
Metasys is designed with the user in mind. It’s easy to configure and deploy and no special training is required to use it. Its enhanced Ready Access Portal (RAP) graphics capability, combined with the tenant user setup capabilities, deliver targeted views of data to any building occupants. For example, a single, customized view for a nurse or school administrator can be delivered to any PC at the site running only a browser. It’s also now compatible with Apple iPhone® or iPod® Touch platforms.
Facility Managers are desperate to better understand – and improve – their site's energy usage and costs. Metasys empowers them to do both. Its Energy Essentials leverages the Metasys Advanced Reporting System to take the existing data and present it in an organized and informative way; providing a full suite of easy-to-configure, easy-to-use and actionable energy reports. Improved Chiller Plant Automation (CPA) will help facility managers operate their chiller plants more efficiently. CPA algorithms are used to operate and sequence plant equipment in an efficient and reliable manner, and to ensure that runtime, starts and stops are equalized across the individual plant components.
Hardware & Software:
Metasys systems seamlessly connect to past, present and future technologies. Others talk about interactivity, connectivity and compatibility. Metasys delivers. With unsurpassed BACnet® interoperability and enhanced wireless performance, Metasys can solve the communication frustrations that multi-site enterprises and campuses face – getting literally thousands of different hardwired and wireless systems, devices and equipment to talk to each other on a single platform. Recent improvements provide even more control options and better information access by users. Metasys has been enhanced by:
- Redesigning Field Equipment Controllers
- Making updates and improvements to Terminal Equipment Controller
- Adding more Wireless and Network Sensors
- Enhancing software and firmware
Wireless technology can be incorporated at one level or all levels of the Metasys system, as well as the building infrastructure. Metasys incorporates the latest wireless technologies into more devices, which increases your control flexibility, streamlines retrofits and results in faster download times. Whether it is at the system’s user interface, network automation, field controller or room sensing levels, Wireless Building Technologies result in increased application flexibility and cost effectiveness.
Security & Fire:
Metasys now incorporates other great building controls systems, the P2000 security management system. The P2000 includes software and network controllers which ensure the safety of employees, and maintain the security of company assets. The P2000 is an open integration platform designed to be interoperable with a variety of security subsystems including access control, alarm & intrusion detection, video surveillance, visitor management and a variety of other safety and security systems.
|Features and Benefits|
|Comprehensive Validation Support Services||Provides a comprehensive approach for validating the facility environment's design, construction, testing, operations, and management|
|Turnkey Facility Automation||Enables Title 21, CFR Part 11 compliance and validation simplicity for facilities in a regulated environment|
|High-performance Facility Operations||Consists of a menu of value-added services that contributes to the optimized performance of regulated facility operations|
Metasys for Validated Environments, when combined with Compliance Assessment and Validation Support Services from Johnson Controls, offers a complete end-to-end solution. It aligns with regulatory codes by addressing both the technological and procedural components required for compliance.
The MVE system can be readily configured to meet the documentation requirements of individual users, company policies and regulatory codes. Johnson Controls incorporates a flexible security model that offers password-based authentication with unique electronic signatures - ideal for use in regulated applications.
Other MVE security features include a secure, audited database function that is designed as the repository for all alarms, operator transactions and trend records
Validation of Environmental Monitoring Methods
There are many ways to perform environmental monitoring. The methods that a company chooses will determine to a large degree whether or not the data is worth the time and effort spent in collecting and tracking it. In order to show that the methods chosen are appropriate, they need to be validated. Validation is a new concept when it comes to environmental monitoring. Environmental monitoring programs are set up to monitor the effectiveness of cleaning and sanitation and to verify that classified environments are operating in a state of control.
Where environmental conditions, such as temperature, humidity, particle content and biological contamination are important aspects of pharmaceutical, biotechnical and or medical device production, validation and qualification of the HVAC system must be performed.
This validation must utilize a risk-based approach, which involves a high level of process understanding and focuses on potential problems, risks, and all suitable countermeasures. The validation must verify that in all areas where drugs or raw materials have air contact, the air cannot adversely affect the quality or efficacy of the product.
To fulfill regulatory requirements, a clean room HVAC system must maintain environmental condition within specified specifications. These conditions must be regularly monitored to ensure constant awareness of environmental conditions, such as temperature, humidity, pressure and particle levels. Digital outputs for alarms must also be monitored to ensure that an alarm will be raised if there is a change in any of the designated parameters.
All such environmentally controlled areas, zones and or rooms must be included in a preventative maintenance and calibration program that will monitor all trends and ensure continued use within the User Requirements specified specifications.
HVAC PERFORMANCE VALIDATION
This fully formatted HVAC Performance Validation is the last in the chain of qualifying tests that HVAC systems are subjected to, before being considered qualified. However environmental validation is required to verify air quality.