The Know-How to Know How
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WARNING. It is a word that always gets your attention. When it comes from the FDA in the form of a letter, it creates significant cause for concern. Medical device consultants at Medical Engineering Consultants believe that your problems are our problems. Here’s what MEC also believes regarding CAPA.
Many problems can be prevented. Step one is to ensure that CAPA not only covers, but is also built into, your entire operation. That includes: CAPA-Protected Full Quality Systems; CAPA-Structured Strategic Development; CAPA-Controlled Policies & Procedures; CAPA-Objective-Driven Ownership and CAPA-Enabled Execution.
Lack of expertise, communication, understanding and training are just some of the possible culprits. Noncompliance regarding rules, regulations and requirements are a few more. At some point, your company will need to take Corrective and Preventative Action. Unfortunately, many medical device and pharmaceutical companies react after a problem presents itself. MEC’s medical device consultants make sure that you are always prepared — and protected — for every existing or potential problem scenario.
Medical Engineering Consultants’ “Identify, Integrate, Execute, Solve and Sustain” approach is designed to put — and keep — medical device and pharmaceutical companies in control. As a result, you’ll encounter fewer barriers to achieving benchmarks and will own your process rather than allowing your process to own you.
Ready to talk CAPA? Contact MEC.