The integrity of data used to ensure the quality of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health.  The topic of “Protecting and Promoting Data Integrity” was presented by Kathleen Culver from FDA (Field Investigator and Drug Preapproval Manager, FDA Cincinnati District), Tracy Moore (Senior GMDP Inspector and GMDP Operations Manager, MHRA), and Paul Vogel (Chairman, Lachman Consultant Services, Inc.) at the recent PharmaLink Conference, which was co-sponsored by Xavier Health and the FDA, held on March 16-17, 2016 in Cincinnati, Ohio.  The conference also included working sessions around the topics of interest and opportunities for networking between the industry participants and attendees from regulatory agencies.  It should come as no surprise that data integrity was one of the most popular formal and informal topics of discussion.

The formal presentations highlighted the importance of data integrity for patient safety, regulatory compliance, and business success.  Recently, data integrity issues in India and China have been captured in the media, but the issues and subsequent concerns regarding data integrity are relevant worldwide.  Now is the time for every firm to be proactive to ensure data integrity both internally and at their contract service providers.  The MHRA put forth its Data Integrity Definitions and Guidance in January 2015 and the FDA has announced that a draft data integrity guidance will be available later this year.  If your firm is not currently taking action to assess and enhance procedures and practices that might impact data integrity, it is likely that your firm has underestimated the complexity of ensuring data integrity and the potential downside risk.  From what we have seen, no easy fixes or solutions exist for data integrity issues.

From discussions at the conference, it appears that most firms in the U.S. are not yet aware of all the elements impacting data integrity.  Many firms don’t seem to understand how data integrity gaps might impact them and, therefore, assume that as long as they don’t have any fraudulent practices, they have no data integrity risk.  It would appear, in speaking to conference attendees, that the regulatory agencies have not yet inspected very many U.S. sites with an emphasis on data integrity practices.  However, it should be noted that U.S. firms are being inspected and are receiving data integrity-related inspectional observations.  Learning from the painful experiences of others, proactive firms are investing in measures to educate their staff and enhance their practices.

For further information and training on the topic of data integrity in the pharmaceutical industry and the importance of taking a proactive approach, please contact either R. George, Ph.D. at or J. Davidson, Ph.D. at