ELM-152-09

ALCOA+ The Meaning of Available [Video]

Data must be available, which means that it must be both retained and retrievable.

Reasonable Amount of Time

Companies must ensure data is available for review within a reasonable amount of time.

During inspections, the time it takes to produce data can directly impact the inspector’s opinion and trust of the company, site or facility.

Can Create Suspicion

If the data is not quickly retrievable, or takes a very long time to produce, this creates suspicion by the inspector.

It should not take days to recover data or records.

Availability

Availability ensures the data meets its use, since it can be applied when the need arises.

The most efficient way of achieving good data availability is normally by recording data electronically.

Accessing records should be practiced routinely so that you are prepared when health authority inspections occur.

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP