GxP Compliance for Computerized Systems
GxP compliance is relevant for computerized systems when the system is used to create, modify, maintain, archive, retrieve, or transmit 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.