Original Record

UK: MHRA Guidance on GxP Data Integrity – The first or source capture of data or information e.g. original paper record of manual observation or electronic raw data file from a computerised system, and all subsequent data required to fully reconstruct the conduct of the GXP activity. Original records can be Static or Dynamic (as per Section 6.11.1 of MHRA – Guidance on GxP data integrity, March 2018).

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