Quality Management and Regulatory Compliance news for professionals in FDA regulated industries.
Maintaining the highest quality levels and strict regulatory compliance affects the bottom line and can be a matter of life and death for medical device, biotechnology, and pharmaceutical manufacturers.
To protect both companies and consumers, and meet increasingly tough FDA and other regulatory body demands, it’s essential to understand and meet the challenges of global corrective and preventive action (CAPA), complaints management, change control, audit management, supplier quality, and overall product quality management.
In addition to the FDA’s stringent 21 CFR Part 11, 54 and 58 requirements, companies face serious regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon life science manufacturers to use the software, hardware, and system processes that ensure only those personnel required to see a given piece of data are in fact allowed to access it.
AssurX quality management software system is designed to support requirements and standards for FDA regulated industries. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document and report all quality and compliance issues across every part of operations—even into the supply chain.
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In four months, the new EU Medical Device Regulation (MDR) goes into effect, which officially means it’s crunch time for devices that need to be certified to the new law. What should companies be [...]
The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical device manufacturers to bring products into compliance. The new law represents [...]