Data Integrity

UK: MHRA Guidance on GxP Data integrity – Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices (as per Section 6.4 of MHRA – Guidance on GxP data integrity, March 2018).

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