About The Data Integrity 2018 – Asia Pacific

Data Integrity is a global problem and currently a major concern with FDA and European Regulatory Agencies.

Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification in companies globally.

The regulatory concern has been responded by the FDA issuing Compliance Program Guide that covers Pre-Approval Inspections. This document became effective in May
2012.

The CPG objective 3 covers the laboratory data integrity audit. Furthermore in August 2014, the FDA issued Level 2 guidance on their web site about the sharing of login credentials for computerized systems and the use of test injections for testing into compliance.

In Europe, the UK’s MHRA issued two versions of a Guidance for Industry on Data Integrity in January and March 2015. This document outlines a data integrity governance system and principles for defining quality and data integrity into processes and systems.

In addition, the guidance defines 19 terms and provides expectations and examples for many of them and therein is where the document’s value lies.

A new draft version of the Guidance was published in July 2016. The WHO guidance is complementary to the MHRA guidance in that it provides guidance for data governance and also expectations for records in both paper and electronic form.

As the regulators are tightening their inspection approaches it is important that managers, supervisors and users in regulated GMP laboratories understand the issues around data integrity and begin programs to ensure that their processes and systems ensure data integrity.