Empower Tip: ALCOA++

In this tip, we begin by defining the principles of ALCOA++.

ALCOA++ is a set of acceptance criteria which must be met for data to be considered trustworthy. In subsequent tips, we will demonstrate how to configure Empower to adhere to these principles.

Let’s see how it’s done!

What does the acronym ALCOA++ stand for? Let’s start with ALCOA:

Attributable – Information is captured in the record so that it is uniquely identified as having been executed by the originator of the data.

Legible – Human readable and permanently recorded. Legible also means that any original data that has been changed or modified by an authorized individual is not obscured.

Contemporaneous – The data should be recorded a the time work is performed and the date/time stamps should follow in order.

Original – The original record can be described as the first capture of information, whether recorded on paper (static) or electronically (dynamic). Information that is captured in a dynamic state should remain available in that state.

Accurate – Data are correct, truthful, complete, valid and reliable.

The first +:

Complete – All data, including any test, repeated analysis or re-processing performed.

Consistent – Consistent generation of records and application of data time stamps in the expected sequence. Functional verification demonstrates that the required information is consistently and completely preserved.

Enduring – Data should be recorded on controlled worksheets, in laboratory notebooks or validated electronic systems.

Available – Records must be available for review at any time during the required retention period, accessible in a readable format to all applicable personnel who are responsible for their review whether for routine release decisions, investigations, trending, annual reports, audits or inspections.

The second +:

Traceable – Data is traceable thru out its lifecycle. Any changes to the data, the context or metadata should be traceable, should not obscure the original information and should be explained if necessary.

It’s that easy!