While every company needs to be concerned about quality, nowhere is it more important than in pharmaceuticals, medical devices, biotechnologies, CROs and other highly regulated industries. These companies not only abide by strict internal quality management standards, but they must also comply with a myriad of rules mandated by regulatory agencies. By centralizing workflow management, consolidating tracking and streamlining regulatory reporting, companies are strategically positioned to identify and manage quality compliance issues across critical business processes.
What is a Quality Management System? While quality itself is evident in the product you produce, what defines it from a tracking and trending perspective can be subjective. Most would agree that at the core of every quality system – and every quality program – is Documentation and Documentation Management. Additionally, CAPA, Deviations/Non-Conformances, Investigation, Audits, Complaints, as well as related processes, are also incorporated. What companies choose to put in their quality management system is as varied as the number of vendors that provide the capabilities.
Why do you need a Quality Management System? The U.S. FDA, the European Medicines Agency (EMEA) and regulatory bodies worldwide expect life science organizations to eliminate fragmented data silos and create a continuous, documented process for managing research, development, distribution and post-market events. Implementing an integrated quality management system not only meets regulatory expectations, it also provides a structured framework that proactively monitors global compliance, reduces risk and lowers the total cost of quality.