“We were migrating our 2 core chemistry analysers, with approximately 100 analytes to a new area of the laboratory but only had an 8-week window to install and validate the new analysers; as well as limited staff to facilitate this transition while continuing to provide a continual service. This was deemed to be unachievable with the current validation methodology, which consisted of Excel spreadsheet-based validations that were complex, not centrally organised, and highly error-prone.

The original plan was to perform the required analysis and use Microsoft Excel to transform and analyse the data. We knew this was going to be an onerous task in terms of resources of staff and time, but we could not see any other way of achieving our objective. This also had to be achieved in a very limited timescale of 8 weeks from start to finish.”

“Validation Manager enabled the seemingly impossible to become possible. We could implement our clinical chemistry analysers in a much-shortened timescale; taking 8 weeks from start to finish to perform precision and comparison studies on around 100 analytes across 2 platforms and duplicate instruments. We validated the second instrument in around 75% of the time it took for the first instrument.

The ease at which data could be uploaded to Validation Manager meant the large volume of data we generated could be broken down into more manageable sections. The data and analysis were also available instantaneously; allowing us to have real-time feedback on the data being generated allowing issues to be identified and resolved. This would not have been possible with the original data analysis plan.

We have already used the software for another study and with our experience already gained made the process more efficient. We will be using this software in more areas of the laboratory and for more varied studies in the future.”