ALCOA is a commonly used acronym for “attributable, legible, contemporaneous, original and accurate”. Data should have all the attribute as mentioned in the definition of ALCOA, further the data needs to be complete, consistent, enduring and available.
ALCOA Plus includes all the attributes of ALCOA, plus an additional attributes “complete, consistent, enduring and available” as completeness, consistency, durability and availability is important to understand and recreate the event.
To understand better, let us define each of the term of acronym ALCOA+:
Attributable: All generated data must be traceable to the applicable instrument and the person who generated the data. The date and time of the collection or generation of data should also be recorded.
Legible: Data should be easy to understand, recorded permanently, and preserved in its original form. There should be no overwriting, All the corrections need to be clearly written with proper justification.
Contemporaneous: Contemporaneous means data should be recorded at the time work is performed. Date and time entries should follow in chronological order. Data should never be backdated.
Original: Source data or Primary is a medium in which the data point is recorded for the first time. This could be an approved form or protocol or a dedicated notebook.
Accurate: To achieve accurate data, the data should be error-free, complete, truthful and it should reflect the observation made. If any correction is made to the data, it should record that who has made the corrected and when it is made.
Complete: Complete data means there is no any deletion of data from the start of documentation including changes made during its life of data.
Consistent: The data should be presented, recorded, dated, or time-stamped in the chronological sequence.
Enduring: The data or information must be maintained, intact, and accessible as an indelible/durable record throughout the record retention period.
Available: The data or information must be easily accessible at any time for review, investigation, trending, routine release decision and inspection or audit, during the defined retention period.