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If a data integrity issue is found, regulatory agencies take action due to the breach. Actions may include warning letters and import holds. A recent number of warning letters issued by the regulator relate to data integrity issues
International regulatory authorities are more concerned with data integrity issues. So the FDA decided to train regulatory bodies like the MHRA to better recognize data integrity issues.
In March 2015, the Medicinal Products Regulatory Agency MHRA published new guidance on “GMP Data Integrity Definitions and Guidance for Industry” to comply with data integrity issues by the end of 2017, the regulatory deadline.
Later in April 2016, the FDA released “Data Integrity and Compliance with cGMP Guidelines for Industry,” but of course there are guidelines for good manufacturing practices per 21CFR (210 211 and 212). Data integrity issues were mentioned, but due to the many regulatory issues and each new update, this has become more of a focus.
