Why Your eTMF Vendor Doesn't Want You To Know About The Exchange Mechanism Standard
Traditionally, TMFs were immense paper files amassing all the required information and evidence for future audit. The manual collation of data and resources was time-consuming and prone to human error. Paper filing is difficult at scale, especially when some trails last more than a decade. To alleviate these issues, companies began storing their Trial Master Files in electronic formats about 14 years ago.