This paper discusses about Data Integrity in calibration processes.
As a concept, data integrity is by no means a new one, it has been around for several decades. Anyhow, in this article, we look at the data integrity more from the calibration process point of view, and focus mainly on the pharmaceutical and regulated industry. At first we take a look at the data integrity generally; what it is, why it is important and acute, what a breach could cause. Also, the ALCOA plus concept is briefly discussed.
Since the impacts of the breach of data integrity can be enormous, it is something that should be a high priority.
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