In CompuCal we have been working on the development and testing of software for regulated industries for over 25 years. We know that the documented validation of the software is a requirement for compliance with FDA, FSMA and other relevant regulations.
We reviewed the report of the 483 FDA forms for the fiscal year 2018 and we present you the most common calibration related observations by industry.
Although IoT hasn't been used yet to its full potential, it has come to stay. The benefits of IoT technology in the prevention of food contamination and cost decrease are multiple. Find out how it can be used in food industry.
The U.S. Food and Drug Administration (FDA) decided to release open source code for its newly created app, MyStudies App.
Calibration Non-conformance Occasionally, in the course of managing your company’s assets, there will be issues. Perhaps the calibration procedure was not followed correctly or completely, results exceeded tolerance levels or a maybe a standard used during a calibration cycle was itself out of date.