Compliant temperature monitoring in cold applications
Low temperature environments in life science applications require secure, 24/7 monitoring to maintain specified temperatures and ensure the safety, purity and efficacy of pharmaceutical/biotech products. As worldwide regulatory organizations refine and establish guidelines for storing, processing, and transporting temperature controlled pharmaceuticals and biotechnology, there is an increasing need for better recording, more customizable reporting, and easy-to-use monitoring solutions.
Key to compliance with GxP regulations for temperature-controlled products is the ability to respond quickly to undesirable conditions in controlled environments. The Vaisala continuous monitoring system sends alerts to designated personnel if temperatures go out of specification or if sensor communication with the system is lost. The viewLinc software is browser-based and accessible from any network location. Reports are customizable, easily exported to a spreadsheet for analysis, and 21 CFR Part 11 compliant. Many viewLinc users note that trend and historical reports are easy to generate on demand and this often becomes an important aspect of their auditing process by customers and regulating agencies.