A planned approach to assessing and managing data risks in a way that reflects the potential impact on

  • Product quality,
  • Patient safety and/or
  • the reliability of the decisions taken

in all phases of the process in which data is

  • created,
  • processed,
  • checked,
  • analyzed,
  • reported,
  • transferred,
  • saved and
  • retrieved

and which is continuously monitored.