In the recent years, there have been an increasing number of reports on the digital transformation cases in the pharmaceutical industry. However, those reports tend to focus on discovery research, marketing or new health care approach using a real-world data set rather than pharmaceutical development and manufacturing.

In this article, challenges relative to effective use of digital technology in the pharmaceutical development and manufacturing are discussed. Also feasibility of effective use of data for knowledge management and work process innovation is assessed. Furthermore, based on the feasibility assessment, impact of data-driven work process transformation is presented.

Although the regulatory requirements for data integrity are appropriately described in the relevant guidelines, the question can naturally be raised on how to afford the industry for their implementation. Hereof, it is worth advancing some proposals for concrete measures of data integrity remediation so that the industry could enforce the compliance without ambiguity in the above regulation specified by the authorities. In this study, we will introduce practical methods for time adjustment, hybrid, and audit trail review in the perspective of data integrity and attempt to share best practices for regulatory compliance regarding data integrity. The study will also detail all the points of time adjustment, hybrid, and audit trail review described at the “DI Remediation Practical Seminar” held in July 2021.