Drug Evaluation Committee Data Integrity of Computerized Systems in the GCP Area (for Management)
Electronic Information Subcommittee
April 2022
In recent years, overseas countries have issued a series of guidance related to data integrity (hereinafter referred to as "DI"), and the possibility that unexpected findings may be made in the event of future conformity surveys in other countries cannot be ruled out.
Task Force 4 of the Electronic Information Subcommittee has been discussing how DI related to computerized systems should be viewed and how to approach management in the GCP area in Japan, with the MHRA's guidance, which also applies to the GCP area, as the main axis. We have created a DI training material for management in the GCP area.
We hope that this document will help you to further understand DI in your company.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Electronic Information Subcommittee, Task Force 4, FY2021
Data Integrity Regarding Computerized Systems in the GCP Area (for management) (1MB)
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