What is ALCOA+ ?

Question

What is ALCOA+ ?

Accepted Answer

ALCOA+ is a set of principles used in data integrity to ensure the reliability and accuracy of data.

ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete
It is commonly used in regulated industries such as pharmaceuticals and healthcare
Attributable means that all data should be traceable to its source
Legible means that data should be clear and easy to read
Contemporaneous means that data should be recorded at the time of the activity
Original means that data should be the first record of an observation or measurement
Accurate means that data should be correct and free from errors
Complete means that all relevant data should be recorded and nothing should be omitted

Accepted Answer

ALCOA+ is a framework or set of principles that ensures data integrity. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain.

As well as being essential for compliance reasons, the ALCOA+ principles are becoming increasingly important to GMP (Good

What is ALCOA+ ?

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