Controller for Stability Chamber Complies with Electronic Records Requirements

Cincinnati Sub-Zero’s stability chamber controller is validated to comply with FDA guidance for electronic records and digital signatures.

Cincinnati Sub-Zero’s stability chambers and stability rooms incorporate the EZT-570S controller, which is now validated to comply with the FDA 21 CFR Part 11 guidance document for electronic records and digital signatures. The stability chambers can be used for International Council for Harmonization (ICH) Q1A pharmaceutical stability testing, shelf life testing, package testing, accelerated aging, and other tests.

The touch-screen controller simplifies chamber operation using data logging, ethernet control and monitoring from any smart phone or tablet, alarm notification via email and/or text message, data file backup, full system security, audit trail, digital signatures, and power recovery options.

Source: Cincinnati Sub-Zero