Drug Evaluation Committee Points to keep in mind when migrating TMF data
Electronic Standard for Medical Information Expert Committee
In recent years, eTMF (electronic TMF) has become widely used, and more and more TMF data is being migrated between companies and systems. eTMF is easier to manage and share data than paper, which helps improve operational efficiency and regulatory compliance.
On the other hand, to properly migrate data such as documents, metadata, and audit trails, it is necessary to work carefully while adhering to the ALCOA+ principles. Attention must also be paid to eTMF-specific risks, such as data integrity and compatibility between systems.
This document summarizes key points of TMF data migration, related regulations, and confirmation items when outsourcing, etc. TMF managers and IT personnel are encouraged to use this document as a reference when planning migration and conducting in-house education.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 3-2