Companies in the pharmaceutical industry are regulated in virtually every aspect of their business. Quality departments look closely at the CFR regulations when producing traditional products (21CFR210/211), biologics (21CFR600), medical devices (21CFR820), and must also recognise the many guidance documents that help them implement suitable procedures to run their processes. If these processes work, delivering the requisite output, we have a definition of a “Quality System”. This Quality Management System (QMS) of procedures then drives quality which in turn drives a company’s performance. If it is done right, the QMS is not a burdensome formality nor a ‘bureaucratic monster’ rather, it becomes a supportive system that enables growth and improved business performance. 

 

How do we know that a company’s QMS is driving the desired success and how do we prove that it is not a drag on the system? There needs to be a monitoring system in place to ensure oversight and provide the indicators that enable management decision making.
 

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