Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity is a foundational requirement of all GXP regulations, there continues to be an increased focus on this topic both from a regulatory and industry perspective as data integrity breaches still drive a significant number of Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations. Moreover, additional guidelines and regulations have been published to establish Data Integrity Standards.
As data integrity programs mature, firms will need to consider transitioning from a reactive model (assessments) to a preventative model and engrain data integrity into their Quality Management Systems and Culture, potentially modernizing historical control strategies to address current controls and risk scenarios. This will lead to exciting new opportunities for people, process, products, and technologies to emerge through the introduction of Data Governance, Data Process Design, Data Analytics, and Big Data initiatives—all with an intent to optimize the availability, usability, and reliability of data to enhance Management Review and Knowledge Management Programs. This transformation journey will demand modern, agile, flexible, and scalable Quality Risk Management strategies and inspired Cultural Change Management.