The life sciences industry operates under uniquely stringent regulatory requirements where technology systems must not only ...

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...

AKM manages every stage of a product’s life, from its planning, throughout production, and up to the end of life, as shown in Figure below. Approval is performed when proceeding to the next stage and ...

Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...

Expectations of regulators, sponsors, and investors are met through efficient and well-designed quality systems and the implementation of a suitable development-stage. Several firms have unique ...

ANN ARBOR, Mich. and HAWTHORNE, Calif. (September 19, 2012) – Space Exploration Technologies (SpaceX), which designs, manufactures and launches the world’s most advanced rockets and spacecraft, has ...

Businesses use quality management systems to improve the efficiency of their processes, which can help increase profitability. Total Quality Management systems use a variety of tools and theories to ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Investopedia contributors come from a range of backgrounds, and over 25 years there have been thousands of expert writers and editors who have contributed. Robert Kelly is managing director of XTS ...