Haversac eTMF™
Use Haversac’s default E6 Good Clinical Practices (GCP) file structure, or customize required documents on a per study basis. Haversac eTMF® users can dynamically require, or not-require, documents based on user answers to qualifying questions. This saves effort. Haversac eTMF® visually depicts the collected, checked, and signed-off status of each document to focus efforts and ensure regulatory compliance. This approval feature, along with folder access control for each study role, makes it practical to distribute collection responsibilities among study participants like Investigators or Monitors.
Haversac eTMF® automatically adds GCP or custom document requirements for each new site, investigator, or laboratory to ensure that no document requirement is missed.
1) Visual Orientation: See the collection status for each folder and document to quickly assess what remains to be done.
2) Direct Access: Go directly to document folders with a single mouse click.
3) Controlled Access: Limit Study, Site, Subject, etc. access based on the user’s study role and assigned sites. This makes it practical to distribute collection responsibilities without compromising confidential material.
4) Assign and empower quality control gate keepers to govern the TMF process.
5) Insert qualifying questions so that only the necessary documents are required.
6) Add qualifiers to records such as license expiration dates or document descriptions.
