Data integrity is absolutely critical in the pharmaceutical industry to make sure that the end products meet all the required quality standards. Essentially, it is a process of maintenance and assurance of accuracy and consistency of the data over its entire life cycle.
Data integrity is critical to the design, implementation and usage of any system that stores, processes or retrieves important data. If the integrity of the data you collect and record is not maintained, there would be no way to ensure that you are producing high quality and safe products. In order to maintain the integrity of data, you must protect it from accidental or intentional modifications, duplication, deletion and falsification.
Of late, pharmaceutical data integrity has been gaining a lot of importance. Any violations concerning data integrity would lead to several regulatory actions like warning letters and alerts that are issued by the FDA. Since a lot of international regulatory agencies are focusing on data integrity, FDA auditors are being trained to recognize data integrity issues in a better way.
Authored by Renee Marcotte, Vice President, Hawkins Point (a Verista Company)