Tuesday, June 16, 2020

Data Integrity- ALCOA+


DATA INTEGRITY - ALCOA+ 



          ALCOA is an acronym Wich stands for

A-attributable
L- Legible
C- Contemporeneous
O- Original
A- Accurate

Now ALCOA has expand to ALCOA + Wich consist of Complete, Consistant, Enduring and Available.


  •  What is data integrity

FDA guidance on data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends.



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