Industry has a tendency to adapt quickly to changing market conditions, especially when money is involved. Government, not so much. When COVID hit the US in March 2020, in-person audits came to a screeching halt. Within months, when it became clear that the pandemic wasn’t disappearing anytime soon, medical device and IVD manufacturers pivoted and within a few months were conducting remote internal audits out of pure necessity. Still, regulators weren’t convinced about the benefits of this newfangled video technology […]

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If you’re among the millions working from home, you don’t have to despair about falling behind schedule with your audit plan. Technology can keep you on track. Working remotely is nothing new, and the pros and cons of doing so are well understood. Yet most audits are still conducted in person. Why? Well, some aspects of auditing are difficult to perform remotely, especially when a direct observation of manufacturing processes or paper documents is involved. Also, the human connection is […]

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You’re mentally exhausted and the end of your medical device audit is in sight. Why not just call it a day and hold a quick wrap-up meeting? Although you and everyone else are eager to get out the door, it’s important that you thoroughly summarize your findings and communicate them to the auditee team immediately after the audit. Yes, everything you say will likely be documented in your report, but this is a key opportunity to add emphasis to certain […]

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For a new auditor, the opening meeting is critical. The manner in which you conduct yourself, and how organized you are, establishes your credibility and sets the tone for the audit to follow. If you appear tentative and unorganized, your audit will probably not go smoothly. With that in mind, here are some tips on how to conduct your next opening meeting. This is based on our experience training more than 130,000 auditors over the last 50 years. Checklist to […]

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