By Greg Vanderstel and Kim Huynh-Ba

Published in: IVT Jr GXP Compliance Vol 25 Iss 2

Published on: March 24, 2021

Introduction: “If it is not written down, it did not happen.” That is the foundation on which contemporaneous data and data integrity are built upon. Contemporaneous, by definition, means “existing, occurring, or originating during the same time.” [1] When this concept is applied to laboratory settings, it refers to recording data, whether it is a time, measurement, or observation when the work is being completed. It is considered unacceptable to record the data using a different means (e.g., a loose piece of paper) then transfer said data later to the appropriately...

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