Don’t Let Data Integrity Be Your Achilles’ Heel
MasterControl recently published an article by Gina Guido-Redden showing that the FDA has been actively defining detailed expectations for data integrity since 1997 when they supplemented 21 CFR Part 211’s predicate rules on records and record keeping, by publishing Title 21’s first set of regulations directly defining the rules for electronic records and electronic signatures (21 CFR part 11). However, more than a decade passed before their first guidance document on this topic was released. In addition to the FDA’s recently published guidance on data integrity, industry has also received formal guidance documents from The Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the World Health Organization (WHO). It’s clear that everyone is publishing on the same topic, at the same time and they are saying the same thing. Our data lacks integrity and the regulators want that to change.
Please read the full article here
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