GxP Compliance for Computerized Systems

GxP compliance is essential for computerized systems. It applies when the system handles clinical data intended for submission to regulatory authorities like the FDA.

To monitor the conduct and reporting of clinical trials, FDA established the Bioresearch Monitoring (BIMO) Program of inspections and audits, to ensure that data from trials meet the highest standards of quality and integrity and conform to FDA’s regulations. FDA’s acceptance of data from clinical trials for decision-making purposes is dependent upon its ability to verify the quality and integrity of such data. To be acceptable the data should meet fundamental elements of quality whether collected or recorded electronically or on paper. 

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