Data Integrity Culture

Data Integrity issues may impact product quality, which ultimately may affect patient safety and patient access to safe products.

In order to ensure product and patient safety, satisfaction and the prevention of data integrity issues, companies must work to develop a culture that makes quality a priority, which includes a focus on data integrity.

A company’s culture and reputation can be damaged by data integrity problems.

Highest Level of Quality and Product Safety

Companies should strive to achieve the highest level of quality and product safety, which is why it’s important to take steps to ensure data integrity compliance and develop methods for handling data integrity issues.

This slide is from a presentation given by Karen Takahasis of the FDA.

It provides a brief, but clear picture of why the FDA considers data integrity so important.

The three takeaways are that:

  • Data integrity issues undermine the safety and efficacy and/or assurance of the quality of the drugs that consumers take
  • Data integrity problems break that all-important “trust” between the patients and the manufacturers and regulatory authorities
  • Data integrity helps to assure that consumers reliance on companies to do the right things is being upheld

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