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FDA’s Data Integrity (2016), Part 11 (1997) and “Appropriate Controls” (1978) – are we back to the future?

Over 25 years ago, as an Automation Engineer, I was responsible for process automation systems (DCS and PLC’s) at a pharmaceutical company. The company happened to be the very first one to get an FDA “Warning Letter” on “computerized systems”. Computerized systems within the industry were regulated at that time solely by 21 CFR 211.68. In 2015 and 2016, approximately 80 percent of all warning letters include a “data integrity” component. The leading observation within that 80% continues to be based on 21 CFR 211.68, a 40-year-old ruling. At the time we received the “Warning Letter”, a task-force...

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