Drug Evaluation Committee Basic Approach to Electronic Regulatory Compliance, including "Use of Electromagnetic Records and Electronic Signatures for Applications for Approval or Licensing of Pharmaceuticals, etc." 4th Edition
Electronic Information Subcommittee
March 2020
The use of electronic data is essential to improve the efficiency of pharmaceutical R&D and post-marketing operations. On the other hand, when computerizing operations in accordance with GxP regulations, the regulations require computerized system validation (CSV) to clarify the requirements of the computerized system and to ensure that the computerized system operates as intended from the perspective of reliability assurance. In particular, the need to appropriately address the risks inherent in electronic data, including risks related to authenticity, readability, and retention, has raised the bar for the use of IT in the pharmaceutical industry. In addition, many regulations and guidelines related to CSV have been issued both domestically and internationally, and trends are changing rapidly. This makes it difficult for individual companies to gather sufficient information.
Therefore, the Task Force 4 of the Electronic Information Subcommittee for FY 2018-2019 revised the "Basic Approach to Responding to the "Guidelines for the Use of Electromagnetic Records and Electronic Signatures for Applications for Approval or Licensing of Pharmaceuticals and Other Drugs, etc.", 3rd Edition, which was revised in 2014, to the 4th Edition based on the latest regulations and system trends. We hope that this document will help you to improve the efficiency of your compliance with the ERES guidelines and other electronic regulations.
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