WHITE PAPER: Live system assessments: Why do them?

Don’t wait for live-systems audits to become mandatory. As more and more companies move to electronic quality management systems, the need for inspectors to conduct audits live in the system has become increasingly common. Prepare now by learning qualification requirements and key advice for installing your own self-inspection program from ex-MHRA inspector Rachel Carmichael.

I have a vivid memory of a certain "pre-exam stress" period as my old production site prepared for my first regulatory inspection in the early 1990s. The theory, even then, was that we would be continuously inspection ready but that didn’t stop us from wanting to ensure that we presented our best face to the inspectors. We would pre-run the obvious tasks, including ensuring that we could create a summary report of the last two of deviations encompassing all departments and all the stages of the events. This is dynamic data in an ever-changing database. Depending on how you requested the search, certain events could be included or excluded. Our endeavor was to make sure that all events were there.

Rachel Carmichael has over 20 years’ experience of pharmaceutical manufacture, control and quality management including nearly 11 years as a GMDP Inspector for the UK Competent Authority, the MHRA.

Click here to download the white paper.

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