Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.
Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.
Despite the best efforts of those responsible for data integrity, the potential for human error is directly and indirectly impacted by the corporate, the national/regional , and quality culture of an organization.
For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”
Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.
During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?”
Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.
