The E-Signature application facilitates compliance with the FDAs 21 CFR Part 11 on IQVISION or TONN8 stations. The E-Signature application runs on IQVISION or TONN8 stations, and once running cannot be disabled or deleted. It records adjustments to protected points in an audit log.
Points on the system can be protected, and when an adjustment is made details are recorded in an unalterable audit log with a date stamp, reason for change and details of the user who made the change.