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