Industry News

FDA Proposed Rule: Quality System Regulation Amendment

On February 23, 2022 the FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) to incorporate the international standard specific for...

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Remote Auditing: Three Keys to Success

This article was originally published in March 2021. Remote audits will continue to be the norm for 2022. While not always ideal, remote audits can be conducted effectively under the proper circumstances.  This article can also be read on MasterControl’s GxP Lifeline....

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Conducting Remote GxP Audits: Three Keys to Success

This article can also be read on MasterControl’s GxP Lifeline. Introduction: The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on course toward product...

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