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+.
|A||Atttributable||The person collecting the data can be identified|
|L||Legible||Data must be readable and permanent|
|C||Contemporaneous||Data must be recorded at the time it was generated|
|O||Original||Data is the source or primary data, not a copy|
|A||Accurate||Data is truthful|
|C||Complete||All required data is included in the record|
|C||Consistent||Data is recorded and presented in the same format, in chronological order where relevant|
|E||Enduring||Data is maintained for its entire required retention period|
|A||Available||Data is accessible in a readable format for the duration of its retention period|
Applying these requirements specifically to the collection of data onto a form has resulted in a number of industry-standard ‘best practice’ approaches:
|Archiving||Maintain readability of original data when correcting an error||Legible|
|Archiving||Copies of attached data (eg, of thermo-paper printouts) should be marked as such||Accurate|
|Compliance||When making a non-standard entry (eg, empty field, alteration to data) provide a reason, along with the date and user’s initials||Attributable|
|Data entry||Ensure that every field required is completed||Complete|
|Data entry||Do not record data onto anything other than the form||Contemporaneous|
|Data entry||Data generated should always be recorded as it is found – even if it’s not expected, or is out of specification||Attributable|
|Data entry||Data should be recorded by the person generating or witnessing it – do not ask someone else to do it for you!||Attributable|
|Data format||Ensure the data is recorded in the format requested||Consistent|
|Data format||Handwritten entries should be in blue or black indelible pen, per company policy, and clearly printed||Legible|
|Rounding||Report the data to the same number of decimal places as the specification or test method indicate||Consistency|
|Rounding||Do not round during a calculation; only round the final calculation result.||Accurate|
|Rounding||A single result averaged from 2 or more data points should be recorded to one decimal place more than the specification to ensure overall accuracy||Accurate|
|Rounding||The final, averaged result should then be rounded to the same number of decimal places as the specification. Averaging should not be used to hide variability in the data spread e.g., all replicate results should meet the specification results.||Consistent|
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.