Where a paper or pdf copy of an electronically signed document is. It is designed to facilitate compliance through education, whilst clarifying the mhra s position on data integrity and the minimum expectation to achieve compliance. This document provides mhra guidance on gmp data integrity expectations for. Mhra 2018 data integrity final guidance data integrity in computer based information systems is a concern because of damages that can be done by unauthorized manipulation or modification of data. During inspections a multitude of problems being found by the pharmaceutical regulatory agency because poor practices. Background the way regulatory data is generated has continued to evolve in line with the ongoing development of. Mhra gxp data integrity definitions and guidance for industry. Mhra gmp data integrity definitions and guidance for industry. Office of communications, division of drug information.
Mhra gxp data integrity definitions and guidance for. In the following section, definitions are given in italic text. A static record format, such as a paper or pdf record, is one that is fixed. Data integrity and compliance with cgmp guidance for industry. Mhra gmp data integrity definitions and guidance for industry, march 20151 draft fda data integrity and compliance with cgmp guidance for industry, april 2016 2 draft pics guidance good practices for data management and integrity in regulated gmpgdp environments, pi 0411 draft 2, 10 august 20163. Mhras gxp data integrity guide published mhra inspectorate.
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