What is ALCOA++ ?
ALCOA++ is a set of principles used in the pharmaceutical and life sciences industries to ensure data integrity — meaning that data is complete, consistent, and accurate throughout its lifecycle. It builds upon the basic ALCOA principles and expands them with additional requirements.
🔹 ALCOA: Core Principles
Each letter stands for a key aspect of good data recording and management:
A Attributable : Who performed the action and when? The data must be traceable to a person.
L Legible : The data must be readable and permanent.
C Contemporaneous : Data should be recorded at the time the activity is performed.
O Original : The first capture of data (or a verified copy).
A Accurate : The data must be correct, truthful, and reflective of the actual observation.
🔹 ALCOA++: Additional Principles
The "++" part includes extended attributes to further ensure compliance and data integrity:
Complete : All data must be included, including any repeat or reanalysis.
Consistent : Data must be in a chronological and logical order.
Enduring : Records must be preserved securely over time (e.g., not on sticky notes).
Available : Data must be readily accessible for review or audit when needed.
✅ Why ALCOA++ Matters
Required by regulatory authorities like the FDA, EMA, WHO, etc.
Helps prevent data falsification, errors, or incomplete records.
Critical in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
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