UK: MHRA Guidance on GxP Data Integrity – Data = Facts, figures and statistics collected together for reference or analysis. All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, thatare generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity (as per Section 6.1 of the MHRA – Guidance on GxP data integrity, March 2018)

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