Drug Evaluation Committee Streamlining of computerized system validation in the area of GCP
Electronic Standard for Medical Information Expert Committee
March 2020
The use of electronic data is indispensable in improving the efficiency of various operations in pharmaceutical R&D and post-marketing activities. On the other hand, when computerizing operations in accordance with GxP regulations, regulations require computerized system validation (CSV) to clarify the requirements of 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, Electronic Standard for Medical Information Expert CommitteeTask Force 4 in FY 2018-2019 examined appropriate and efficient ways to promote CSV in the GCP area, and summarized "cost-effective computerized system validation including the use of cloud computing" and "efficient supplier audits and efficient use of CSV documents prepared by suppliers". This report summarizes the CSV activities of each company. We hope that this report will help you to improve the efficiency of your CSV activities. For ease of use, the CSV document table is also available in Excel.