Data Integrity, Quality Culture, Truth and Lies Can We Set Up an Objective System?

Karen Ginsbury, PCI Pharmaceutical Consulting Israel Ltd, Petah Tikva, Israel

Regulators around the world have come to realize that Data Integrity is not limited to the analytical laboratory.  While there are endless opportunities in analytical testing (as the auto emissions scandal showed) for “gaming the system” obtaining genuinely accurate data in a company at all levels appears to be far more challenging than a superficial approach indicates.

FDA has issued a draft Quality Metrics guidance and is starting to collect data.  What is the purpose and can measuring help us identify and prevent issues?

This presentation will:

  • Examine the problems with capturing data appropriately
  • Investigate how opportunities exist of conscious and unconscious manipulation during data analysis
  • Look at corporate culture as an unwitting sponsor of cheating
  • Propose some preventive actions starting with most senior management and people and ending with data collection plans

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