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Posted by on in Quality Systems

quality-audits.pngSo we all understand that internal audits and supplier audits are required by regulation.  We also understand that if a company does not have an audit schedule or has one but is not able to fulfill the schedule an observation or noncompliance is likely from the FDA or Notified Body.  However, for the moment, let’s get past the obvious and focus on the real benefit of audits.

If a company manages the audit program in a productive manner (i.e., not as a punitive weapon against employees or suppliers) they will quickly determine the “real” benefits of a solid, productive audit program.  The challenge often is that a company does not utilize qualified auditors.  Not simply qualified in auditing techniques but an auditor that is familiar with the regulations and most importantly the subject material they are auditing.  In this blog, let’s discuss the internal audit program.

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Posted by on in Quality Systems


Through the development phase you have planned, designed, verified/validated your product and then carefully designed and implemented your manufacturing processes.  Your product begins commercial use and nothing should go wrong………right?   I think we have all heard the classic phrase "the best laid plans of mice and men often go astray".  This applies equally in the medical product world.  Either you don’t anticipate everything that may occur in the real life application of your product (e.g., user training, human factors, drug interactions, off-label use, short-term vs long-term use, larger patient population demographics, etc.) or at a minimum you find ways (designs/manufacturing) to improve upon your product.  If a company has a robust Customer Feedback/Post Market Surveillance Process,  a strong Corrective and Preventative Action (CAPA) Process and a responsive Design Control Process, they can respond efficiently and effectively while gaining customer loyalty.

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