ELM-152-02

The Difference Between ALCOA & ALCOA+  

Now, let’s discuss the details of the data integrity requirements and expectations.

Data Integrity can be defined according to several parameters.

You will hear the terminology ALCOA or ALCOA Plus, which refers to the basic attributes needed in order to ensure that data integrity is under control.

Five Characteristics

ALCOA is an acronym to help us remember five characteristics of good data:

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate

ALCOA+

The plus (+) portion of ALCOA consists of additional characteristics of good data, including the following:

  • Complete
  • Consistent
  • Enduring
  • Available

It is important to consider all of these aspects when evaluating data integrity compliance.

By first understanding what each aspect of ALCOA+ means, individuals then able to evaluate data (risk assessment) within their work against the principles of ALCOA+.

In the event that control of the data does not meet one of the principles, remediation in this area is required in order to bring control of the data up to standards.

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Note that this course will provide an overview of ALCOA and ALCOA+.

In courses four and five of this program on data integrity awareness, we’ll cover ALCOA in more detail as it applies to paper and computer records.

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP