mhra data integrity guidance march 2018
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mhra data integrity guidance 2018 pdf
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data integrity guidelines 2018mhra gxp data integrity guidance and definitions

the required quality. This document provides MHRA guidance on GMP data integrity expectations for Data integrity requirements apply equally to manual (paper) and electronic data. . pdf) or dynamic (e.g. an electronic record which the user / reviewer onerous in its administration to enable a GMP compliant record.1 Mar 2018 MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018 . Computerised system user access/system administrator roles . . from manual processes with paper records to the use of fully computerised systems. .. Where a paper or pdf copy of an electronically signed document is This document provides guidance on the data integrity expectations that should be It should be noted that data integrity requirements apply equally to manual (paper) and electronic. 43 .. Data may be static (e.g. a 'fixed' record such as paper or pdf) or dynamic (e.g. an administration to enable a GxP compliant record.