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.
“FDA believes that quality agreements can be extremely valuable in delineating the activities of all parties involved in contract research and development arrangements.”
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.