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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.
Additional description Changes can be protected at two levels, single authentication and dual authentication. Changes protected by dual authentication require a second user to authorise the change.
ModelTypeDownloads
  TXTPDF
TONN 8 E-Signature Application for 250 secured pointsTONN-ESIG-250 TXT
PDF
Specification sheet (English)
TONN 8 E-Signature Application for unlimited secured pointsTONN-ESIG-UNL TXT
PDF
Specification sheet (English)
TONN 8 E-Signature Application 250 secured points upgradeTONN-ESIG-UP250 TXT
PDF
Specification sheet (English)
IQVISION E-Signature Application for 1000 secured points. NBIQV-ESIG-1000 TXT
PDF
Specification sheet (English)
IQVISION E-Signature Application for unlimited secured points. NBIQV-ESIG-UNL TXT
PDF
Specification sheet (English)
IQVISION E-Signature Application 1000 secured points upgrade. NBIQV-ESIG-UP-1000 TXT
PDF
Specification sheet (English)