DATA INTEGRITY Data integrity, an area of increasing priority in today’s laboratory world and “The focus area” when it comes to regulatory compliance such as 21 CFR Part 11 and Eudralex Annex 11. Considering the number of warning letters from USFDA and other such regulatory bodies issued to pharmaceutical and medical devices manufacturers across the globe, Data integrity is the “Buzz word” in today’s audit. WHAT IS DATA INTEGRITY? Data integrity refers to the overall completeness, accuracy and consistency of data during its entire life cycle. Though seems simple, the whole process of genuinely generating, maintaining & transforming data with completeness and accuracy is a challenging task for any organization. This white paper discusses the issues faced by organizations in a

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