Times are changing. Increasing competition, regulatory scrutiny and tightening margins are a few of the challenges facing Life Sciences Companies. As a result, drug and device manufacturers are evaluating every aspect of their operations to identify opportunities for greater efficiency and productivity.
The role of quality management is quickly changing. While compliance remains a top goal, increasing global competition and industry pressure are forcing quality teams to focus on driving company-wide performance in addition to maintaining compliance.
Compliance is king. At least it has been for decades as far as quality teams at pharmaceutical and medical device companies are concerned. And now, FDA, is taking an emboldened step with another autocratic change.
Pharmaceutical companies face some very real challenges within clinical quality management. There are pressures to not only to ensure compliance but to get approved drugs to market safely and effectively without spending additional funds on redundant quality management tools that may already exist in their organization. One way to address these challenges would be for pharmaceutical companies to create a global GxP solution that ensures visibility across the supply chain as well as automate quality processes, sufficient tracking of all correspondence, and more.