Data Integrity in the Pharmaceutical Industry

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Data integrity is crucial in pharma; it is the key factor in determining the quality of a product. With recent regulatory concerns related to poor practices, findings have shown that the data that often takes years to compile can barely make it through inspections in some cases. When the integrity of information is compromised, so is the reliability and validity of the products. If that isn't concerning enough, consider the incredible amount of time and funds wasted in avoidable situations.

Three factors contribute to data integrity- accuracy, completeness, and consistency. Without these three, pharmaceutical companies risk producing poor quality products and losing millions, and sometimes billions, of dollars. Companies cannot recover the time spent building, gathering, and recording data in these unfortunate cases.

Accuracy. The accuracy of data should not be subjective, guessed, altered, or copied. Recording data precisely as received should not vary with each person or system gathering information. Good practices for collecting and recording data should prevent inaccuracies.  

Completeness. Is your data complete? For companies to get the most valuable data, systems need to be designed that ensure the accuracy of the data and its fullness. Holes in the system where data is incomplete may result in spending more of the budget fixing the errors, or in some cases, being unable to include the data altogether.

Consistency. Why is consistent data-keeping a challenge? We hear it time and time again, "Consistency is key." When recording data, deliberately recording accurate and complete results consistently will maximize the potential of your data. It will help deliver a higher quality product and manage costs preventing the loss of millions (even billions) of dollars. One way to ensure data integrity is to invest in high-quality data management products and services. Managing data can be a challenging task. Outsourcing may be the best option to provide the maximum results.