August 30, 2021
regulations compliance
Published by Joachim Nuyttens at August 30, 2021
Categories

Audit trail requirements on GxP computerized systems

According to Wikipedia an audit trail is a chronological record providing documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. The first uses of audit trails date back to ancient civilizations when rudimentary methods emerged to manage goods, soldiers and financial transactions. Audit trails to ensure data integrity came into the spotlight when US regulation 21CFR Part 11 was issued in 1997. Part 11 requires the use of secure, […]
February 20, 2021
Published by Joachim Nuyttens at February 20, 2021
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Common FDA warning letter observations in 2020

Last year was a bizarre year and, hopefully, one of a kind. Not only did Covid-19 affect our personal and professional lives, it also had a huge impact on regulatory inspections which were delayed or executed remotely. In this article I present the main result of a data analysis on pharmaceutical FDA warning letters of 2020. I used the same tools as presented in one of my earlier articles on FDA warning letters. As shown on the pie chart below […]
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