Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document published on 23rd January 2015 provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry – click on the link Data integrity definitions and expectations for a copy. This guidance is intended to complement existing EU GMP, and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
UPDATE November 2017 – TAKE NOTE! We now also have a 20-minute online Data Integrity course designed to bring your team up to speed on this important topic – click here for more details.
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