Our topic this year will be on Data Integrity. If you are interested in sharing your experiences, please contact Michalle Adkins at firstname.lastname@example.org or call 610.212.3594 to discuss this opportunity.
Here is the Forum abstract:
Life Sciences Industry Forum
Topic: Complete, Consistent, Accurate Breadcrumbs: Data Integrity Unveiled
In April 2016, the FDA issued Data Integrity and Compliance With CGMP Guidance for Industry. This is on the heels of a lot of related 483s, warning letters, and more severe actions with respect to this issue. Data Integrity is defined as complete, consistent and accurate data that is attributable, legible, contemporaneously recorded, original or true copy, and accurate. Data Integrity includes all aspects of instrumentation, field devices, automation, IT, and procedural solutions. While the Guidance document provides several recommendations, the implementation of these can vary based on the interpretation of “appropriate controls”, “critical data”, “data vs record”. The Life Sciences Industry can use risk-based strategies based on process understanding, knowledge management technologies, and business models to meet core regulatory requirements.
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