21 CFR Part 11

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 can rest assured that their data is fully protected according to 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

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