Following on from the previous blog Form Design – it’s all about the white space, comes the exciting part deux: Form Use – the right way to fill in a form.
There is a general misconception that data integrity failures only result from acts of deliberate fraud. … the majority of issues relate to:
- bad practice,
- poor organisational behaviour and
- weak systems
which create opportunities for data to be manipulated.
[Companies can take] some basic behavioural, procedural and technical steps to significantly improve their systems.
David Churchward, MHRA
Another topic that would seem so simple on the outside but so frequently goes wrong.
So, let’s start by assuming you’ve followed the advice from the previous blog and have created forms with a logical flow, suitable fields and space which encourage users to provide the correct information.
What other guidance is required to generate compliant primary records?
This is where we stumble into the territory of Good Documentation Practice and the art of ALCOA. ALCOA defines some specific requirements for generating records from forms which comply with requirements of data integrity.
The acronym was coined by FDA officer Stan Woollen in the early 1990s, which he took from US aluminium company, Alcoa Inc. As a well-known corporation, this name was easy for him to remember but you could make up your own.
Data integrity is the means by which the accuracy, consistency and reliability of data is assured throughout its lifespan. It continues to be a hot topic, accounting for significant numbers of findings during regulatory audits.
ALCOA’s original principles were sourced from the FDA’s Code of Federal Regulation for Good Laboratory Practice (GLP) but it has been expanded since its inception and has been renamed ALCOA+.
Applying these requirements specifically to the collection of data onto a form has resulted in a number of industry-standard ‘best practice’ approaches:
Training your staff to follow some of these simple maxims may help reduce the risk of data-related inspection findings.
Some data recording requirements may have to be defined for your specific needs. Creating a robust and well-tested procedure will help your staff produce consistent and compliant data that should keep you out of trouble with the inspectors!
If you want some help in achieving more compliant data management, PharmOut can assist – we offer instructor-led, 1-day workshops which now may also be conducted virtually. Visit our training pages for more information. Online training for Good Record-Keeping is also available.
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