From Concept to Medicine - A Comprehensive Drug Development Journey

128 - Data Integrity in QC (S9E8)


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Uncover the high importance of data integrity in analytical labs, focusing on ALCOA+ principles and secure electronic systems. Learn what is meant by all of the above, the framework for quality and reliability, starting with attributable. Examine how it needs to be as trustworthy in systems, as it is to get it on paper, by securing controls. Gain insight into the purpose of audits, and look at how they prepare those responsible, along with reviewing potential consequences that would result from not fulfilling expectations.

Walk through practical tips on how to prevent data from disappearing, and how systems to prevent issues come about in the first place. Explore some areas and reasons that something could be problematic and why good and reliable practices are important for protecting the public. Gain insight into how all of this plays out into the work of the labs and helps to make sure that regulations are all fulfilled, while at the same time improving the quality for consumers.

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From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

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