Form Use – the right way to fill in a form

Form-Use

Form Use – the right way to fill in a form

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+.

AAtttributableThe person collecting the data can be identified
LLegibleData must be readable and permanent
CContemporaneousData must be recorded at the time it was generated
OOriginalData is the source or primary data, not a copy
AAccurateData is truthful
CCompleteAll required data is included in the record
CConsistentData is recorded and presented in the same format, in chronological order where relevant
EEnduringData is maintained for its entire required retention period
AAvailableData 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:

TopicRequirementPrinciple
ArchivingMaintain readability of original data when correcting an errorLegible
Original
Accurate
Complete
ArchivingCopies of attached data (eg, of thermo-paper printouts) should be marked as suchAccurate
Legible
Complete
ComplianceWhen making a non-standard entry (eg, empty field, alteration to data) provide a reason, along with the date and user’s initialsAttributable
Accurate
Complete
Data entryEnsure that every field required is completedComplete
Data entryDo not record data onto anything other than the formContemporaneous
Original
Accurate
Data entryData generated should always be recorded as it is found – even if it’s not expected, or is out of specificationAttributable
Accurate
Data entryData should be recorded by the person generating or witnessing it – do not ask someone else to do it for you!Attributable
Accurate
Data formatEnsure the data is recorded in the format requestedConsistent
Accurate
Data formatHandwritten entries should be in blue or black indelible pen, per company policy, and clearly printedLegible
Consistent
Enduring
RoundingReport the data to the same number of decimal places as the specification or test method indicate Consistency
RoundingDo not round during a calculation; only round the final calculation result.Accurate
Original
RoundingA single result averaged from 2 or more data points should be recorded to one decimal place more than the specification to ensure overall accuracyAccurate
RoundingThe 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
Accurate

 

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.