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DATA INTEGRITY

FOCUS

Data integrity refers to the guarantee with which a set of information is managed during the creation and storage process. According to this approach, the data must comply with different criteria throughout its lifecycle. Defined by the Food and Drug Administration Agency, it is the so-called ALCOA license. The data must therefore be:

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate

In addition, have also been added the CCEA criteria for Data Integrity (ALCOA Plus):

  • Complete
  • Consistent
  • Enduring
  • Available

In summary, integrity is defined when all these criteria are met. Data analysis can transform the pharmaceutical industry, in fact, the correct and precise use of the data is a fundamental requirement in this field. It is necessary to use software designed for this correct management. It’s a matter of using standard rules and procedures, keeping updates through the control of procedural, operational errors, and validation routines.

Ensuring data integrity therefore requires:

  • Adequate quality and risk management systems.
  • Adherence to scientific principles and complete and detailed documentation of everything that is done (good documentation practices).

In a context where becoming a data-driven company brings a great competitive advantage, data integrity is, therefore, a fundamental requirement. Have a look at some of our Tableau Software case history in the Pharmaceutical industry.

Case History