Carrier has released a new Life Sciences version of the i-Vu® building automation system (BAS). i-Vu® for Life Sciences is an environmental control system that provides the tools, reports, and insights to manage the critical environments of pharmaceutical, biotech, and medical device manufacturers in compliance with the United States Government Food and Drug Administration (FDA) regulation 21 CFR Part 11.
i-Vu for Life Sciences is a solution in Carrier’s Healthy Buildings Program, a suite of offerings to help deliver healthier, safer, more efficient, and productive indoor environments. Carrier is a part of Carrier Global Corporation (NYSE: CARR), the leading global provider of healthy, safe and sustainable building and cold chain solutions.
Maintaining quality and consistency
FDA-regulated manufacturing facilities such as laboratories, pharmaceuticals, and biotech companies require that building environments be precisely controlled to maintain environmental conditions such as temperature, humidity, pressure, and airflow.
Carrier’s i-Vu for Life Sciences closely monitors and controls these critical parameters, helping maintain the quality and consistency of the products created within these facilities. The 21 CFR Part 11 regulation requires that the performance of the i-Vu system be documented and validated using electronic records and signatures and that operator authentication, authorization, and activity within the BAS be managed and monitored securely.
Automatic Alarm and Dedicated Server
“Our new i-Vu for Life Sciences system helps provide customers with the confidence that their manufacturing environment is producing high-quality products while also helping to eliminate product waste,” said Mark Jones, Business Manager, Controls, Carrier. “An automatic alarm will alert if something goes wrong, so customers can respond before the manufacturing process is affected. And electronic records help ensure that they maintain compliance with 21 CFR Part 11 requirements.”
i-Vu for Life Sciences also addresses the security requirements associated with FDA-regulated manufacturing. A dedicated server can be located securely within any facility, while multi-use facilities can use multiple or separate servers. Each server can reside on an organization’s existing Intranet and host a single, secure database. These servers utilize Secure Sockets Layer (SSL) 128-bit encryption, BACnet whitelist firewall, and advanced security password policies. Operator logins can also be managed securely using LDAP or Active Directory.
Additional functions and features
i-Vu for Life Sciences also requires operator signature and comment to acknowledge critical alarms, while tracking and documenting all procedural actions. Any attempted change to critical environmental controls prompts user verification, including the electronic recording of the rationale for the change in a secure audit log. To verify activity, system administrators can easily query the system’s database by operator, location, or date. A powerful reporting engine also generates digitally signed and approved compliance reports.
i-Vu for Life Sciences also supports many standard features, including vector floor plan graphics, customizable dashboards/graphics/trends/reports, and the ability to integrate third-party sub-systems and software using BACnet®, Modbus®, and LonWorks® protocols. The new i-Vu for Life Sciences software is available through Carrier sales offices worldwide.
