MHRA Data Integrity Consultation 2016英文书.pdf

1 2 MHRA GxP Data Integrity Definitions and Guidance for Industry 3 4 Draft version for consultation July 2016 5 6 7 8 9 Background 10 11 The way in which regulatory data is generated has continued to evolve in line with the introduction 12 and ongoing development of supporting technologies, supply chains and ways of working. Systems 13 to support these ways of working can range from manual processes with paper records to the use of 14 computerised systems. However the main purpose of the regulatory requirements remains the same; 15 having confidence in the quality and the integrity of the data generated and being able to reconstruct 16 activities remains a fundamental requirement. 17 18 19 Introduction: 20 21 This document provides guidance on the data integrity expectations that should be considered by 22 organisations involved in all aspects of the chemical1 and pharmaceutical development lifecycle. 23 24 This guidance should be read in conjunction with the applicable regulations and the general guidance 25 specific to each GxP. Where GxP-specific references are made within this document (e.g. ICH Q9), 26 consideration of the principles of these documents may provide guidance and further information. 27 28 Arrangements in place within an organisation with respect to people, systems and facilities should be 29 designed, operated and where appropriate adapted to support a working environment and 30 organisational culture that ensures data is complete consistent and accurate in all its forms, i.e. paper 31 and electronic. The effort and resource applied to assure the validity and integrity of the data should 32 be commensurate with the risk and impact of a data integrity failure to the patient or environment. 33 When taken collectively these arrangements fulfil the concept of da