Drug Evaluation Committee Overview of FDA CSA Draft Guidance and Discussion and Consideration of its Application to the GxP Domain
Electronic Standard for Medical Information Expert Committee
July 2024
In recent years, the advancement of digitization has transformed computer software quality assurance into a more difficult and labor-intensive activity. Against this backdrop, in September 2022, the FDA issued a new draft guidance on computer software quality assurance (Computer Software Assurance). Electronic Standard for Medical Information Expert CommitteeTask Force 4 has reviewed this Draft Guidance and has prepared a document that provides an overview of the Draft Guidance and discusses and considers its application to GxP. We hope this document will be useful for your understanding of the Draft Guidance.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2023 Task Force 4