Empower Tip: ALCOA++

In this tip, we learn about Accurate

Accurate means data are correct, truthful, complete, valid and reliable.

(Note: I recommend reading Tip 411 before reading this tip)

Let’s see how it’s done!

Things to consider:

Controls that assure the accuracy of data in paper records and electronic records include, but are not limited to:

Qualification, calibration and maintenance of equipment, such as balances and pH meters

Validation of computerized systems that generate, process, maintain, distribute or archive electronic records

Systems must be validated to ensure their integrity while transmitting between/among computerized systems

Validation of analytical methods

Validation of production processes

Review of GxP records

Investigation of deviations and doubtful and out of specifications results

Other risk management controls within the quality management system

It’s that easy!