However, within the 21 CFR 11 requirements lurked another high-risk component: “Data Integrity”. Simply put, Data Integrity (“DI”) is the assurance that data records are accurate, complete, intact and maintained within their original context so as to make the data trustworthy.
In pharmaceutical QC labs, there are often many manual steps in the performance of a routine QC analytic test to release a product (Figure 1). High risk areas were associated with the amount of human input required and how closely that input was monitored and verified.
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