Drug Evaluation Committee Basic Approach to e-Regulation Compliance, including "Use of Electromagnetic Records and Electronic Signatures for Applications for Approval or Licensing of Drugs, etc." (Fourth Edition)
Electronic Standard for Medical Information Expert Committee
March 2020
The use of electronic data is essential for improving 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 for computerized systems and to ensure that computerized systems operate 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, in FY 2018-2019 Electronic Standard for Medical Information Expert CommitteeTask Force 4 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 Drugs, etc.", Version 3, which was revised in 2014, into a fourth edition based on the latest regulatory 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.