Laboratory Informatics, Data Integrity, and You

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In 2015 the FDA issued warnings to 10 companies for data integrity violations, the most in the last 10 years. And between Jan 2015 and May 2016, 75% of all FDA warning letters included lapses in data integrity. In response to the growing risk of these problems, in April 2016, the FDA released the draft guidance “Data Integrity and Compliance with CGMP Guidance for Industry” to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. With inspectors and auditors putting a priority on the integrity of your data, do you know if your laboratory informatics systems and procedures are ready to comply? Are you addressing integrity issues on a case-by-case basis or are you assessing your overall CSV program? In this presentation, you will learn where the biggest gaps and risks are and recommended ways to mitigate them.