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Data Integrity White Paper Alert

FreeAnalystWP

TURN YOUR DATA INTO KNOWLEDGE

Sound data is the foundation to good decisions and good science.  In the Life-Science industry patient outcomes, product quality, safety and efficacy all rely upon vast amounts of data that is generated throughout the product lifecycle.  This means that patients, brand equity and reputations have the potential to suffer greatly without a strong data integrity foundation.

What is Data Integrity?

FDA has defined data integrity as the completeness, consistency and accuracy of data[1]. Complete, consistent and accurate data have the following attributes (using the acronym ALCOA):

  • Attributable
  • Legible
  • Contemporaneously recorded
  • Original or a true copy
  • Accurate

Download the white paper to learn more.

See our Infographic. What do Goldilocks & Life-Science Companies Have in Common?

[1] Source: FDA Data Integrity and Compliance with CGMP, Guidance for Industry. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf >
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