Drug Evaluation Committee Overview of FDA CSA Draft Guidance and Discussion and Consideration of its Application to the GxP Domain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 Against this backdrop, in September 2022, the FDA issued new draft guidance on computer software quality assurance (Computer Software Assurance). Task Force 4 of the Computer Software Assurance Subcommittee has reviewed the Draft Guidance and prepared a document that provides an overview of the Draft Guidance and discusses and considers its application to GxP. We hope this document will be useful for your understanding of the Draft Guidance.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