Reduce FDA Form 483 Observations With a Complete EQMS
How can a connected EQMS help you mitigate the risk of Form 483s from the FDA?
U.S. Food and Drug Administration (FDA) inspections are commonly followed by a list of objectionable conditions and compliance violations, listed in a Form 483 or warning letter. When it comes to medical device and other life sciences manufacturing, the same problems routinely top FDA 483 lists — problems involving quality responsibilities and procedures.
A complete, end-to-end QMS that digitises and integrates all quality processes will help FDA-regulated manufacturers reduce the risk of Form 483 observations and warning letters. A digitally connected EQMS unifies document control, quality events, change control, training, customer complaints, audit management, and much more.
- Learn the most common reasons for FDA Form 483 observations and warning letters in medical device manufacturing environments.
- Explore how a robust QMS solution helps automate, streamline, and effectively manage processes commonly cited in FDA 483 lists.
- Understand the FDA’s approach to medical device regulation and inspection observations to more easily identify and mitigate compliance issues.
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MasterControl Quality Excellence is a comprehensive software solution designed to streamline quality processes and ensure regulatory compliance in a wide range of industries. It provides an easy-to-use, secure platform for managing document control, training, audits, corrective and preventive actions, and supplier management. It also offers an integrated suite of tools for data analysis, reporting, and data sharing across the enterprise. The software is designed to help organisations reduce the risk of noncompliance and improve overall quality. It helps organisations to improve their quality management systems, meet regulatory requirements, and increase efficiency.
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Proven QMS Tools to Reduce the Risk of Form 483s
FDA inspections can be stressful, and findings cited in a Form 483 list can have significant consequences depending on a manufacturer’s response, including warning letters, consent decrees, or worse. FDA-regulated companies must maintain a robust EQMS to help reduce the risk and impact of compliance infractions.
With nearly three decades of experience in the rigorous FDA environments, MasterControl has developed a complete EQMS that combines industry best practices with an integrated suite of tools that improves quality processes and associated documentation. It provides all the tools needed to be audit-ready and reduce the risk of Form 483s and warning letters.
Achieve new levels of quality excellence.
See how MasterControl’s comprehensive EQMS solution can transform quality management and reduce the risk and impact of FDA Form 483 observations.
Download NowLooking for more information about FDA Form 483s and compliance?
Contact us today to learn how MasterControl makes it easier for medical device manufacturers to meet FDA requirements and avoid Form 483s.
