Whitepaper: Meeting modern data integrity and compliance requirements

FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP that the increasing number of data integrity-related cGMP violations identified during its inspections was ‘troubling’…

In fact, 21 out of 28 warning letters issued by the agency between January 2015 and May 2016 involved data integrity issues in drug manufacturing.

Ultimately, whether you are a drug manufacturer, clinical research organisation (CRO) or pharmaceutical R&D company, the accuracy and completeness of data is critical for safe product development, and any breach of data integrity could have serious implications for human health.

cGMP violations identified through routine regulatory inspections are manifold. Regulators do witness some intentional violations, perhaps the destruction of paper records, or the failure to take corrective action to address open investigations into interrupted, missing, deleted or lost data. However, in most cases non-compliance is not the result of overt misconduct, but stems from inadequate or poorly implemented procedures, ineffectual computer system security – think shared logins and permissions – and poor understanding of and adherence to internal practices, SOPs and controls.