By Calvin Kim, Samsung Biologics

Published in: Pharma Manufacturing

Published on: February 21, 2023

Key lessons: As projects progress from pre-clinical to commercial, the amount of critical data grows as the project scales.

With the increasing complexity of treatments and intricacies of the relevant processes, there is an equally growing need for robust DI controls that allow accurate decision-making based on reliable data.

These challenges can be further compounded if digitized solutions brought in to elevate efficiency and protect data integrity are implemented without a clear understanding of the process they are trying to improve and how they could achieve this. It is therefore essential to implement a robust approach to data integrity whilst ensuring that regulatory requirements are met.

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