This is the final of a 3-part series on data integrity in the GMP area and I’ve added a couple of bonus items on the same topic. PART 1 described the history of how we arrived where we are today regarding regulatory agency concerns about data integrity. PART 2 continued with regulations and guidance on this topic as well as some of the enforcement actions that global authorities have taken against companies who ran afoul of the requirements. We close with PART 3 that identifies some specific actions firms may take in this area, conclusions overall from the series and a detailed list of references complete with links.
AND MORE, we provide the entire series content in one document and two additional documents: 1) the complete text from the CY 2015 FDA warning letter deficiencies in the are of data integrity and 2) the Eudra GMP reports of non-compliance published in 2015 that identify data integrity