TAI provided preliminary engineering to effectively assess the current system architecture and implement a migration platform and approach with preliminary engineered drawings to provide effective cost estimation for the installation of the preferred system upgrade.

TAI migrated the outdated Environmental Monitoring System, EMS, to a new state‐of‐the‐art EMS that allows for isolated monitoring capabilities in all GMP and non‐GMP areas at the facility. The new system was engineered to meet GMP and FDA 21 CFR Part 11 requirements, moving the facility away from a multi‐system process for monitoring and controlling critical data points, towards a fully independent EMS. The new EMS is flexible and user-friendly, capable of expansion and offering features that were not part of the existing system. The new EMS will optimize workflows and provide easy operation, with custom interfaces, accessed by using new thin clients to view the system at operator terminals. The new system will be robust and secure to fully address the cybersecurity requirements of the Client and the FDA.

TAI provided Preliminary Engineering, Design, Specification, Documentation and Estimating services to include all required site evaluation, engineering, and documentation services to upgrade the Facility’s monitoring system.

Specifically, TAI provided the following:

• An assessment and record of the existing control systems and associated network, utilizing drawings provided to TAI as the basis for our as‐found drawings;
• Documentation of the existing and recommended networks, as well as documentation of the inventory and segregation of Building Automation and EMS components and sensors related to Remote I/O panels;
• Narrative Report defining recommendations for monitoring system and network upgrade;
• An Implementation Plan for upgrading and placement of the controllers, components, wiring and networks to the new system;
• Modification of an existing Systems Architecture drawing to understand the expected project scope of work; and
• Total Installed Cost Estimate to capture project equipment and installation costs.