In this age of intense scientific discovery, life sciences companies are becoming increasingly complex. Biopharmaceutical and medical device businesses are developing more complicated products in the form of bio-similars, implantables, combination products, and others. These companies are operating across multiple industry segments (pharmaceuticals, diagnostics, medical devices, OTC, etc.), and they are entering varied emerging markets. In this environment, current quality management systems (QMS) have not kept pace with a growing variety of products and technological complexity. A new QMS framework is needed to inject heightened effectiveness and efficiency into the industry quality processes.