For records to be considered reliable and trustworthy they must comply with the principles of ALCOA:


Who made the record or created the data and when?


They must be able to be read and understood for the lifetime of the record, without having to refer to the originator for clarification. The information may be needed in five, ten or twenty years’ time, perhaps after the originator is no longer available


The record must be made at the time the activity was performed


Earliest record of the data, could be a written observation, printout or electronic file or a certified copy thereof. The information must not be written on a post-it, piece of scrap paper, sleeve of a lab coat etc. and then transcribed or saved in a temporary location


No errors or editing without documented changes


Recently ALCOA has been updated to ALCOA+ which is widely been used by the WHO and FDA.

ALCOA+ focuses on Complete, Consistent, Enduring and Available data.


All data is available, nothing has been deleted and evidence must be available in an audit trail


Data is recorded chronologically with data and time evident again in an audit trail


Data is accessible for an extended period of time


Data is accessible over the lifetime of the product