What is ALCOA? If this is the question in your mind then we are ready to answer your question this is one of the questions being asked when thinking of joining QA and some other departments as data integrity is very important in manufacturing, research, etc. Nowadays regulations are stringent and most of the observations during regulatory audits are data integrity issues. 

ATTRIBUTABLE

LEGIBLE

CONTEMPORANEOUS

ORIGINAL

ACCURATE

 COMPLETE – CONSISTENT – ENDURING – AVAILABLE

To tackle the data-integrity issues the principles of Alcoa were introduced in the 1990s and CCEA was added to it in 2010 and named it ALCOA+

Attributable – all the activity like entering the online data either in paper or electronic form must be attributable to the person doing it, in a simple sense when we see data, it must tell us when it was done and who has done the work, this can be accomplished by date and signature of the person doing the work.

Legible – data entered in documents shall be legible to others such as auditors. legible means data should be clear and readable

CONTEMPORANEOUS –  This means recording data online, recording the data, at the time it was done, there should be no backdated data, or recording the data after completion of the process. it should be done when it is done.

Original –   Original data is the paper or electronic medium, where the data is initially recorded, original data must be preserved and if any duplicates are made, they must be differentiated from the original records.

Accurate – No errors or simply the data should be free from errors, any addendums or revisions should be done according to good documentation practices.

Complete – As by the word complete, we can tell that whatever the data recorded must be complete, from beginning to end, and no deletions are present, and the data should be traceable and should identify the person performed or recorded and the time the test was done.

Consistent –  Data should be consecutive like one after other in an orderly manner,  and should be date and time stamped.

Enduring – The data should be appropriately stored, so that data should be long lasting without any loss, data can be stored in paper and electronic format.

Available – Data should be readily available when required by auditors, and internal audits, and during inspections, data should be properly indexed to facilitate its retrieval.