Fridge & Freezer Temperature Monitoring, Alarming & Reporting for GxP Compliance
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 guidelines for storing, processing, and transporting temperature-controlled pharmaceuticals and biotechnology, there is an increasing need for better temperature data recording, more customizable reporting, and easy-to-use remote monitoring solutions.
Key to compliance with GxP regulations for temperature-controlled products is the ability to respond quickly to undesirable conditions in freezers, fridges and cold rooms. The Vaisala monitoring system is ideal for cold room, fridge and freezer monitoring applications, sending alerts to designated personnel if temperatures go out of specification, or if sensor communication with the system is lost.
The system software is browser-based and easy to use for remote monitoring, alarming and reporting. Reports are customizable, easily exported to a spreadsheet for analysis, and 21 CFR Part 11 compliant. Trend and historical reports can be scheduled or generated on demand for any monitored fridge, freezer or cold room, simplifying the audit/inspection process by customers and regulating agencies.
We offer several application notes and white papers to help with fridge and freezer monitoring and validation for GxP-compliance
- 8 Steps to mapping a chamber
- Quality & Metrology in cGMP Environments - 10 articles
- Assessment of Vaisala viewLinc Continuous Monitoring System Compliance to 21 CFR Part 11 Requirements
- Assessment of Vaisala vLog Mapping/Validation software Compliance to 21 CFR Part 11 Requirements
- The Care & Feeding of an Environmental Monitoring system: Getting to GxP Compliance and Staying there
We invite you watch our on-demand webinars on measurement, monitoring and mapping.