ARTICLES BY KIP WOLF
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Attributable Data Integrity in Modern Biopharma Using ALCOA Principles8/29/2022
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
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The Data Integrity Body of Knowledge Expands with New & Pending Guidances12/20/2021
Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.
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Data Integrity In Supply Chain Risk Management During Zero Trust6/21/2021
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.