Six Ways To Optimize Your Quality Management System And Ensure FDA And ISO Compliance

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How much does quality cost? Most companies would be hard-pressed to translate “quality” into dollars and cents. What they realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.

This is especially true in the strict FDA and ISO environments, where quality is closely incorporated in regulations and standards. The FDA explicitly states that the overarching philosophy of the Current Good Manufacturing Practice (CGMP) Regulations is this: Quality should be built into the product, and testing alone cannot be relied to ensure product quality. Similarly, the eight quality management principles that form the basis of the ISO 9000 series of standards articulate the importance of making quality an integral part of a manufacturer’s daily operations.

Six Ways for Optimization
This white paper posits that an optimal quality management system is the foundation for long-term regulatory compliance, and consequently, for enduring market success. Without a solid quality infrastructure, your organization is simply not equipped to face the challenges of the regulatory environment and the vicissitudes of a competitive market. In addition, an optimal system will spare you the unnecessary, and often staggering, cost of poor quality.

MasterControl Inc., a leading provider of quality management software solutions for companies in the FDA and ISO sectors, offers the following tips for optimizing your quality management system to ensure high-quality products/services and continuous compliance.


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