The FDA requires that electronic records and electronic signatures are certified, trustworthy, reliable, and essentially equivalent to paper records and handwritten signatures as described in 21 CFR Part 11. Users of the Kneat.Gx application are assured that their data is fully protected per the regulatory requirements.

General Features

  • Closed System
  • Validated Compliance
  • Accurate and Complete Records
  • Records in Human Readable Form
  • Records Easily Retrieved
  • Access Controls
  • Secure, Computer-Generated, Time-Stamped Audit Trails
  • Rules Enforced Workflows
  • Electronic Signatures Bound to Electronic Records