Executive Summary | Why is Electronic CDS Data a Major Data Integrity Concern for Regulators?

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Heather Longden
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Pharmaceutical manufacturers are bound by regulatory agencies to follow and employ current good manufacturing practices (cGMPs) for the preparation and analysis of drug products. Additionally, they have significant responsibility to demonstrate, document and file regulatory information before releasing new products to the market following Good Laboratory Practices (GLPs) and for proving clinical safety and efficacy following Good Clinical Practices (GCPs).

Analytical techniques, such as chromatography, are extensively used for measuring and quantifying components in a mixture, supporting many claims of product quality required by these GxPs. The Chromatography Data Systems (CDS) used to capture, process and document the data have raised concerns about suspected regulatory and quality issues at some labs because the applications provide important benefits in terms of time-stamped, automated audit trails, change histories and (where used) secure electronic signatures. These technologies make data falsification more difficult and more traceable than with paper records; however, the added complexity and volume of available metadata presents its own challenges when devising comprehensive review processes.

What follows is a look at how chromatography systems address specific concerns and challenges when demonstrating data integrity to an auditor or regulator.


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