Noncompliance with Quality Standards

A new white paper Noncompliance with Quality Standards: What's the Risk to Executives by Michael Heyl Attorney at Law, discusses major risks to upper management in highly regulated environments (e.g. pharmaceutical, medical device, laboratory, etc.) when compliance with the FDA is not achieved. The white paper also discusses safeguards that can be taken to avoid fatal violations and calamitous million-dollar fines.

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Weighty Responsibility and Noncompliance with Quality Standards

While heavily regulated companies rely on many employees to achieve compliance with quality standards it is upper management that is primarily responsible for quality and noncompliance breaches. To avoid the dreaded FDA 483 statement - management has not ensured that the quality system requirements are effectively established and maintained, and/or million dollar fines, upper management needs to establish the following quality and compliance safeguards:

1) Regular Communication with a Quality Management Representative
2) Quality Management Review Improvement
3) A Quality Policy that Supports Actual Quality Efforts
4) Technology Enablers that Track and Enforce Noncompliance with Quality Standards

Paying a Heavy Price for Noncompliance with Quality Standards

The U.S. Supreme Court has continually upheld the right of the FDA to prescribe broad inspectional authority in life science environments and provides upper management representatives with the motivation that will ensure their interests are protected and processes are noncompliance with quality standards.