Taimei Technology’s eTMF business expert team provided early consultation and diagnosis of eTMF management capabilities. The international implementation team worked with the previous implementation team, formulated implementation plans, communicated effectively, and helped the client quickly establish overseas eTMF management systems.
I. eTMF is based on the CDSIC Reference Model. It determined the required eTMF list based on the project’s characteristics and established an eTMF directory template for international projects.
II. Taimei Technology’s eTMF business experts provided definitions of international eTMF management roles and responsibilities, a QC checklist, and the CDSIC Reference Model to help Stemexcel quickly determine the document management workflow and ensure document quality.
III. eTMF allowed the use of a blind/non-blind independent folder management method to ensure permission isolation and avoid the risk of blindness caused by human errors to the greatest extent.
IV. Since Taimei’s overall system interface is bilingual, eTMF supports both Chinese and English environments. When executing clinical trials abroad, research teams can quickly start using Taimei’s system.
V. Taimei’s team executed a User Acceptance Testing (UAT) Plan to verify that the eTMF management system would meet the needs of the client. The steps included:
Building the UAT environment
Confirming UAT participants
Writing the UAT script
Having test users follow the script to perform UAT
Tracking and resolving UAT problems to ensure that the system quickly enters a stable period of operation after it goes online.