Travel has been restricted due to the Corona Virus and many companies have turned or will be turning to alternatives to complete their audit schedule.  Remote Auditing is one of the alternatives to re-scheduling an audit. So what are the essentials for a good remote audit? The FDA, as part of the Medical Device Single…

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Each year the FDA provides spreadsheets summarizing the areas of regulation cited in these observations at the following website:  FDA.gov  The spreadsheets are not a comprehensive listing of all observations but represent the a number of times it was cited as an observation on a FDA Form 483.     Top categories for 2018: #1 Quality…

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Metric Reporting

Metrics, This one word can cause many emotions, fear, trembling, excitement, or dread! I have experienced all of these emotions when it comes to metrics. That Pareto Chart ascending or descending in at a particular elevation or curve can have a profound effect upon us! The FDA has recognized the importance of Quality Management System…

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