Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

FDA 21 CFR part 820 is a set of Quality System Regulations established by the U.S. Food and Drug Administration (FDA) to direct Medical Device manufacturers and ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics and devices) are known as current good manufacturing practices (CGMPs).  Current good manufacturing practice requirements are set forth in this regulation, and are consistent with the requirements for quality systems contained in applicable international standards, like ISO 9001 and ISO 13485.  Quality System Regulations for medical device manufacturers do not regulate how a manufacturer must produce its product. Rather, the regulation defines the framework and elements that must be present in a quality system.

Impact

This regulation affects any medical device manufacturers who produce any product intended for human physical use, whether at the design, production or packaging stage. All components of the lifecycle of any of these products are overseen by this regulation, and must adhere to the quality standards laid out by the FDA.

These quality standards cover:

•     Design Controls
•     Document Controls
•     Purchasing Controls
•     Identification and Traceability
•     Production and Process Controls
•     Acceptance Activities
•     Nonconforming Product
•     Corrective and Preventive Action
•     Labelling and Package Control
•     Handling, Storage, Distribution and Installation
•     Servicing

Each manufacturer and their executive management are responsible for adhering to the regulations within part 820 and for maintaining an effective quality management system. Management must establish an effective quality policy and maintain an organizational structure that allows for effective risk assessment and risk mitigation.

Challenge

Many companies are managing quality risk assessment documents in disparate systems or even paper-based systems making it difficult to leverage data across divisions and teams. It is necessary to have a seamless integration as changes in requirements are made, or errors are detected and faults must be traced to the design and to ensure that compliance with regulations can be verified.  In the event that product failures are experienced in the market, it is necessary to determine where that defect occurred, whether in the original product design, during manufacturing or in post-market usage. Closing the loop to ensure post-market feedback is incorporated into the design and manufacturing process provides a higher quality product and improves FDA compliance.

The Dyadem Solution

Dyadem provides comprehensive Quality Risk Management (QRM) solutions that enable global Medical Device companies to reduce risk management effort by 50%-80%. In addition to improved quality and reduction in compliance risks, Dyadem also offers an integrated lifecycle model linking all parts of design and production risk analysis. This provides full traceability for FDA compliance and the identification of critical quality attributes to align design with manufacturing.