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ALCOA+ I Data Integrity Principle: ALCOA+ I Basic Concept on Data Integrity I FDA I 21 CFR I EU

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In the pharmaceutical industry, maintaining data integrity is paramount to ensure product quality, patient safety, and regulatory compliance. The ALCOA+ framework—comprising Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available principles—serves as a comprehensive guide to uphold data integrity throughout the data lifecycle.

1. Attributable

Data must clearly indicate who performed an action and when it was performed, ensuring traceability and accountability.

Example: In a pharmaceutical laboratory, each test result is linked to the analyst who conducted the test, along with the date and time, facilitating traceability and accountability.


2. Legible

Data should be recorded in a clear, readable, and permanent manner to prevent misinterpretation in the future.

Example: Handwritten entries in laboratory notebooks are made legibly, and electronic records are formatted with readable fonts and layouts to ensure clarity.


3. Contemporaneous

Data must be recorded at the time the activity is performed, providing a real-time account of events.

Example: During clinical trials, researchers document patient observations immediately as they occur, ensuring real-time data capture.

4. Original

Data should be the original record or a certified true copy, preserving its authenticity.

Example: Original electronic data files are securely stored and protected from unauthorized alterations, ensuring the authenticity of the information.


5. Accurate

Data must be correct, truthful, and free from errors, reflecting the true value.

Example: Analytical instruments are regularly calibrated, and data entries are cross-checked to ensure accuracy in test results.


6. Complete

All data, including any repeat or reanalysis performed, should be included to ensure the full dataset is available.

Example: Batch records in pharmaceutical manufacturing include all required data entries and documentation before the batch is released for distribution.


7. Consistent

Data should be presented in a consistent manner, with all elements of the record following a chronological order.

Example: Process data is recorded chronologically, with date and time stamps in the expected sequence, ensuring consistency in data presentation.


8. Enduring

Data should be recorded in a durable medium to ensure it is preserved throughout its lifecycle.

Example: Data is recorded in controlled worksheets or validated electronic systems to ensure durability and accessibility over time.


9. Available

Data must be readily accessible for review or audit throughout its retention period.

Example: Data is stored in systems with high availability architecture, enabling fast retrieval by authorized personnel whenever needed.


Adherence to these ALCOA+ principles ensures that data remains trustworthy and compliant with regulatory standards, thereby safeguarding product quality and patient safety.

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