Drug Evaluation Committee Data Integrity Regarding Computerized Systems in the GCP Domain (for Management)
Electronic Standard for Medical Information Expert Committee
April 2022
In recent years, a number of guidance documents related to data integrity (hereinafter referred to as "DI") have been issued overseas, and it is undeniable that unexpected findings may be made in the event of a future conformity survey in other countries.
Electronic Standard for Medical Information Expert CommitteeTask Force 4 has examined how DI related to computerized systems should be viewed and how to approach management in the GCP area in Japan, based mainly on the MHRA's guidance, which also applies to the GCP area, and has prepared DI education materials 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 Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2021 Task Force 4
Data Integrity Regarding Computerized Systems in the GCP Area (for management) (1MB)