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Editor's Message

Data Integrity: A Hot Button Issue

Data integrity is always a popular topic with our readers, so I was excited to put together an issue around the topic, although perhaps “excited” is not the best word to use when it comes to data integrity. After all, it is a focus of concern for many regulatory agencies, including the U.S. FDA, who issued a Q&A guidance in December (1).

To keep readers informed, I have attended many PDA conferences featuring talks on the topic, including a 2016 workshop in London (2). From these presentations and also from talking with members of PDA’s Data Integrity Task Force, it has become clear to me that data integrity must be supported by all levels of an organization.

Fortunately, this issue’s cover story features a good overview on the current state of data integrity. The second feature from Ann Milliman at Baxter offers some strategies for handling audit trail reviews. The third feature, from members of the planning committee behind this year’s PDA Data Integrity Workshop, looks at the impact of big data technologies on data integrity strategies.

Speaking of the latter article, consider attending the 2019 PDA Data Integrity Workshop in September. Data integrity will also be addressed at the 2019 PDA/FDA Joint Regulatory Conference. I will be at both events, so if you see me, feel free to let me know what you think about the Letter.

Before I close out this message, I want to introduce Madeline Cusick, our summer intern. Currently, she is a junior at Georgetown University majoring in English and interested in journalism. She hopes to learn as much as possible about the intersection between science and communications in the upcoming months. Madeline has been fully involved in editing this issue and she is enthusiastic about continuing to help out with the PDA Letter!

References

  1. U.S. FDA, Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry, Dec. 2018
  2. Stauffer, R. “Workshop Offers DI Insights from Regulator, Industry.” PDA Letter 52 (July/August 2016)54.