The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade.

Several examples of poor data integrity practises have demonstrated the consequences it can have on a biotech's future, particularly when is occurs at an early stage of development.

In episode 11 of Let's Talk Quality, I was joined by Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics.

Brian has a large remit, covering regulatory, quality and clinical, and is passionate about all things data. He speaks about his background with the FDA, his journey to Kriya, and how he is implementing a culture of data integrity in his current role. We discuss the following:

• The importance of data integrity in pharma and biotech.
• What does good data integrity look like?
• How Brian drives a culture of data integrity in his current role.
• Data integrity gone wrong - real life examples.
• The consequences of poor data integrity practises.
• When biotech's should be thinking about developing more robust quality systems.
• How to start building better data integrity practises into your business.
• The challenges of overseeing multiple functions in a start-up biotech.

Huge thanks to Brian for joining us on the show and sharing some best practises for implementing great data integrity practises. For a biotech leader, especially if you're in preclinical studies, ensuring you are implementing and embedding a culture that drives data integrity excellence is paramount to your future success.

I hope you enjoy the show!