Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation.

Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices.

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.