FDA 21 CFR Part 11

FDA

  • The VisiWinNET system is
  • Fully FDA-compliant
  • By the user administration
  • By recording any parameter change
  • By start/stop recording
  • By password changing
  • By encoded data storage in a Data base

 

Under "FDA 21 CFR Part 11" since 20.03.97 electronic data administration and the use of electronic signatures with data monitoring and control software has been mandatory in certain industrial sectors in the USA (FDA = Food and Drug Administration).