ALCOA is a commonly used acronym for “attributable, legible, contemporaneous, original and accurate”. Data needs to be complete, consistent, enduring and available along with all other attributes mentioned in definition.
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 PLUS:
Definitions:
Attributable: All generated data must be traceable to the applicable instrument and the person who generated the data. Record should be kept for the date and time of collection or generation of data.
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. Records of any correction made to the data including who has made the correction and when the correction is made, should be kept.
Complete: Complete data means there is no any deletion of data, from the start of documentation including changes made during the 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, for the defined retention period.
Data Integrity in the Pharmaceutical Industry
One thought on “Data integrity Principle: ALCOA to ALCOA Plus”