The role of an integrated LIMS solution on supporting data integrity in current good manufacturing practice (cGMP) environments

The US FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP1 that the increasing number of data integrity-related cGMP violations identified during its inspections was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, FDA compliance as well as 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.

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