Computer Software Assurance: What You Need to Know About the FDA’s Upcoming Guidance

The FDA is expected to release a new guidance document, Computer Software Assurance for Manufacturing, Operations and Quality System Software, in 2022.

This new guidance is highly anticipated because it will actually streamline some of your computer software systems.

The FDA is leaning towards a Case for Quality (CfQ) approach with less emphasis on a compliance approach allowing device manufacturers to focus on enhancing device quality and patient safety. Two issues identified by the FDA have driven their new approach:

1. The industry lags in implementation of automated systems and new technologies due to the lack of clarity, outdated compliance approaches, and perceived regulatory burden.

2. Companies often struggle to understand the root cause of issues in order to improve product quality.

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About the Author

Sandy Hedberg has over 20 years of professional experience in quality and regulatory affairs in medical device, pharma, and biologics industries. She has participated in assisting companies with responses to consent decrees and audit findings to the FDA. She has extensive experience in risk analysis, creation of quality procedures, computer system validation, auditing, and authoring regulatory submissions.

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