Maintaining compliance Maximizing performance

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1 Life sciences MVE SErvices Maintaining compliance Maximizing performance

2 Life sciences MVE SErvices Understanding your data. Understanding your system. Metasys for Validated Environments (MVE) from Johnson Controls captures and manages critical facility data to meet FDA Electronic Records and Signature requirements (Title 2 CFR Part ). Plus, it offers unparalleled state-of-the-art building management performance for your entire facility. While your MVE Building Management System (BMS) is designed, installed and validated to control, report, integrate and manage your data for compliance purposes, you can benefit from ongoing expert service support from Johnson Controls. Even though required by federal regulations and recommended by industry guidelines, the BMS often is not administered, maintained or serviced properly. If not addressed, BMS operations could degrade to a point where the system is not in compliance. Johnson Controls Solutions To Common BMS Problems Include: Routine monitoring and assessment of system performance Tracking unacknowledged alarms Identifying and reducing nuisance alarms Applying critical BMS software patches Training users on proper BMS operation Ensuring proper system security administration Reviewing user access Maintenance plans for software, data and data management Documenting system configuration changes

3 System-Focused Service Our MVE Service solution encompasses a wide range of services to help ensure your MVE system continues to perform flawlessly. Ongoing service support will also provide your MVE Users with expert help when they need it, and will provide documentation to prove you are committed to maintaining your system properly and in compliance with current regulations and industry guidelines such as Good Automated Manufacturing Practices (GAMP). We ll develop a service plan to meet your long-range goals, focusing on your system performance requirements and critical priorities while helping you to achieve your compliance goals. Whether you choose all of our services or the base offering, the goal is to provide you the assurance that your system is performing the way it was designed, day in and day out. The MVE service solution can include: System inspections MVE software version baseline and variance BMS network diagnostics MVE software patches/upgrades notification MVE user access report User support Alarms/failure analysis Performance management MVE Software Version Baseline and Variance This service will provide you a baseline of the software that was initially installed, shows you when updates and changes were made, and will help identify any unauthorized changes, allowing you to investigate and make sure you have documentation in place to explain that change. BMS Network Diagnostics Routinely, we will perform diagnostics to ensure that the MVE network is performing properly. Just like any data network, changes and additions may cause the performance of the MVE network to degrade over time. BMS Network Diagnostics will uncover any trends that may lead to performance issues, allowing you to address the issues before they become critical. We can also use this to create benchmarks to measure future performance of your system and to show how your system compares with the performance of other MVE systems. MVE Service Report BMS Network Diagnostics We executed an onboard tool in Metasys called NC Diagnostics. The following is an analysis of that information. o NCU- diagnostics: Found NCU- to have an idle time of 57%. We would like this value to average above 70%. We recommend adding an NCU and address it as making it the network node manager therefore relieving NCU- of those responsibilities. All other NCU s performance diagnostics were within normal parameters. We investigated the Data Collector and Data Server for configuration and basic performance of read and write time and found those values to be well within normal parameters. The collector is configured as a service and is connected to a remote MRS with other MRS s as backup for fault tolerance. System Inspections What are you doing to make sure your system is current and meeting compliance requirements? Johnson Controls will conduct periodic on-site visits to evaluate your Metasys system. This inspection will provide you with a basic assessment of your overall compliance status, identify any configuration issues or concerns and benchmark your facilities performance against other Life Science facilities. MVE Software Patches/Upgrades Notification We will notify you automatically of MVE software patches, enhancements and upgrades as they become available. This assures that you will always have access to the most current and capable software. We will consult with you on the scope of the patches and upgrades to help you identify the scope and applicability to your system and the risks of not applying the patches or upgrade. This allows you to plan in advance for Change Control.

4 MVE User Access Report (2 CFR Part ) You can be certain who has been logging in and logging out of your MVE system and how they have been using it. This periodic report summarizes all user activities. It will identify potential problem areas, for example if there are excessive auto logouts it may indicate operators are leaving workstations unattended, creating security problems. Usability reports can also provide data for optimizing system configuration. It s also a valuable tool for ensuring 2 CFR Part compliance since it allows you to review who is accessing the system and how they are using it. Alarms/Failure Analysis We ll help you proactively look at alarms and system events. By reviewing alarm history and looking at trends, we can work with you to identify nuisance alarms, develop an alarm reduction strategy and implementation plan. As part of this service, we create an initial baseline report, and then review alarm and failure data against it. We can also benchmark your alarm rate against other MVE systems at other sites. This service identifies potential alarm problems and recurring failures. It can also help alleviate operator workload and system stress. MVE User Access Report Failed Logins The following shows the number of unsuccessful login attempts by user. Failed User Attempt asmith 2 bjones 2 csmith djones 4 esmith 4.5 fjones g smith 2 gsmith 3.5 hjones ismiht ismith jjones 2.0 metasyssyagent 2.5 Metasyssyagent 44 nsmith 3.0 ojones.5 psmith p.smith 0 qjones 7 rsmith 8 sjones s.jones tsmith 5 Grand Total 2 asmith bjones csmith djones esmith fjones g smith gsmith hjones ismiht ismith jjones metasyssyagent Metasyssyagent nsmith ojones psmith p.smith qjones rsmith sjones s.jones tsmith User Login Failed Performance Management This service takes a more in-depth look at your MVE data center from the IT and database management perspective. We will consult with your data center IT support representatives to discuss and identify current best practices and strategies for database management, performance improvement, security and archiving. We can then work with you to implement strategies that can improve overall Data Center performance and security. MVE Service Report User Support Have a question or a concern? You can have direct access to knowledgable and experienced MVE resources. When you contact the Johnson Controls user support service, we ll quickly address your MVE questions and concerns. Performance Management Basic Information Currently, the AwxLog32 Database is consuming MB of disk space. The EventLog table has a total of 2,240,687 records at this time. The GenEventLog table has a total of,245,370 records at this time. Currently, the JCIHistorianDB Database is consuming 4,29MB of disk space. The tblactualvaluedigital table has a total of 73,657,385 records at this time. The tblactualvaluefloat table has a total of 83,3,987 records at this time. The size of the database does not indicate any problems. These values will act as a baseline in order to determine rate of growth in the future. Compared to other databases, these would be considered to be large in size.

5 Since the MVE building management system operation may have a direct impact on product quality, or data from the system may be used to support product disposition decisions, it is critical that you continually monitor, assess and update the system capabilities as needed. Johnson Controls provides the advanced technology, system expertise and compliance knowledge to support your system.

6 Real Estate Projects Facilities Energy Workspace Technologies Infrastructure Consulting 2008 Johnson Controls, Inc. P.O. Box 423, Milwaukee, WI 5320 Printed in USA PUBL-3855 (Rev. 3/08)