Automated Logic’s New WebCTRL for Life Sciences System Meets 21 CFR Part 11 Regulations
KENNESAW, Ga. -
Automated Logic has released WebCTRL® for Life Sciences, an environmental control system that helps pharmaceutical, biotechnical, and biomedical firms ensure compliance with the United States Government Food and Drug Administration’s (FDA’s) 21 CFR Part 11. Precise control of environmental conditions including temperature, humidity, pressure, and airflow are crucial in FDA-regulated manufacturing facilities such as hospitals and laboratories. WebCTRL for Life Sciences closely monitors and controls these critical parameters, helping maintain the quality and consistency of the products created within these facilities. WebCTRL 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. Automated Logic, a leading provider of innovative building-management solutions, is a part of Carrier Global Corporation (NYSE: CARR), the leading global provider of healthy, safe and sustainable building and cold chain solutions.
WebCTRL for Life Sciences includes a comprehensive set of features to support the Food and Drug Administration’s 21 CFR Part 11. These features support compliant site requirements to document and validate system performance, accuracy and reliability through electronic records and signatures. In addition, WebCTRL for Life Sciences enables compliant sites to closely monitor and properly manage operator authentication, authorization and activity within the system. As a software supplier to FDA-regulated companies, Automated Logic also meets Good Automated Manufacturing Practice (GAMP) and ISO supplier requirements.
“21 CFR Part 11 compliance is crucial for the success of Life Science facilities,” said Mead Rusert, president, Automated Logic. “WebCTRL for Life Sciences provides the electronic records needed to help ensure accuracy, reliability and security of system data. As a result, our clients can improve product quality, reduce product waste and increase operational efficiencies – all while minimizing their risk of non-compliance.”
To ensure data integrity, WebCTRL for Life Sciences addresses data security that is critical to FDA-regulated manufacturing. A dedicated server can be securely located within your facility; multi-use facilities can be supported with multiple, separate, or hierarchical servers. Each of these server configurations can host a single, secure database and use your existing Intranet. In addition, WebCTRL servers employ Secure Sockets Layer (SSL) 128-bit encryption, BACnet whitelist firewall and advanced security password policies.
WebCTRL 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.
In addition to the 21 CFR features, WebCTRL for Life Sciences also supports standard features including thermographic floor plans, Time-lapse™ graphics, customizable dashboards, and the ability to integrate third-party sub-systems using industry standard protocols.
For more information on WebCTRL for Life Sciences, please visit www.automatedlogic.com. If you would like to see a demo of the WebCTRL system or the new WebCTRL 8 features, please contact your local Automated Logic dealer.