Icq consultants1/8/2023 ![]() ![]() ![]() According to data integrity guidelines, data must meet the Attributable, Legible, Contemporaneous, Original and Accurate principle - ALCOA, for short. Data integrity failures account for almost 20 per cent of warning letters in devices, 15 per cent in drugs and over 40 per cent in biologics.ĭata integrity describes the completeness, consistency, and accuracy of Good Manufacturing Practice (GMP) relevant data in a pharmaceutical facility. In fact, FDA records show that number of 483 warning letters issued in 2015 was 19, but this increased to 98 in 2019. According to a whitepaper by ICQ Consultants, issues related to data integrity are increasing. Pharmaceutical manufacturing is synonymous with legislation, and rules related to data integrity require a high level of attention.
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