What is the difference between ALCOA and ALCOA Plus?
What is ALCOA?
In the early 90’s, regulatory agencies defined the concept of Data Integrity by using ALCOA, which is an acronym that refers to Attributable, Legible, Contemporaneous, Original, and Accurate.
What is ALCOA Plus?
In later years, the concept of ALCOA Plus was introduced to the industry, which features the five main principles of data integrity (i.e. Attributable, Legible, Contemporaneous, Original, and Accurate) plus the four attributes of being complete, consistent, enduring, and available.
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Difference between 21 CFR part 11 and EU Annex 11
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