Traduction in progress
AUDITTrak™ is the component of TrakSYS™ 6.0 that supports compliance with FDA-21 CFR Part 11 through the creation of detailed audit records any time a change is made either to the TrakSYS™ configuration and/or to data that has been collected. TrakSYS™ can be configured to require single or double digital signatures whenever a change is made. Additionally, it allows extensive notes capture for contextualized details concerning the change. Web-based reports allow authorized users to query and view all audit information recorded to the TrakSYS™ database.
