Airedale NHS Foundation Trust uses Validation Manager to accelerate instrument validation and verification from planning to review
About Airedale NHS Foundation Trust
Airedale NHS Foundation Trust provides acute, elective, specialist and community care for a population of more than 200,000 people across a 700-square-mile area of Yorkshire and Lancashire. Pathology at Airedale General Hospital is delivered by Integrated Pathology Solutions LLP, a joint venture between the pathology departments of Airedale NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust and Harrogate and District NHS Foundation Trust.
1 Goal
Managing recurring change with a consistent validation process
Airedale’s pathology laboratories routinely perform verifications and validations in accordance with ISO 15189 standards. These activities are typically required in response to three types of change:
1. Introduction of new reagent formulations: These changes may be introduced at short notice and can be unavoidable when suppliers modify assays in response to incidents or opportunities for improvement.
2. Introduction of new equipment: This may involve repatriating tests to improve service responsiveness or refreshing analysers, typically on a three- to seven-year cycle depending on the equipment. These projects can generally be incorporated into planned change schedules as more notice is given.
3. Changes to software: Updates to analyser PCs, middleware or the laboratory information management system (LIMS) may be required to maintain operation, strengthen cybersecurity, improve quality, or support reagent and equipment changes.
The laboratory selected Validation Manager because it could support validation and verification work aligned with ISO 15189, ISO 17025 and IVDR requirements. The team also considered its international applications and NHS laboratory references, which indicated that the platform could enable more consistent documentation, support advanced statistical analysis and allow staff across different grades to participate in the process.
2 Implementation
From initial projects to wider laboratory use
Airedale first used Validation Manager to process precision data part-way through validation and verification work on two Beckman Coulter AU5800 chemistry analyser updates.
The TOSOH G11 was the first new instrument for which the team used Validation Manager across the full process. Planning, sample analysis, data analysis and review were completed in one week. The project included precision studies, patient bias/comparison, and stability studies.
As Airedale has brought more methods back in-house, Validation Manager has helped the team carry out validation and verification work more quickly, without recording results by hand or moving data between spreadsheets.
Use of the platform has since expanded. Colleagues at Bradford Royal Infirmary used Validation Manager extensively during their laboratory refresh in summer 2026. Airedale’s Haematology department began using it for an equipment refresh in August 2026, while the Biochemistry department plans to use the solution for all and any future validation activities, including changes to methodology, new analysers, and new methods.
3 Result
A complete instrument project in one week
Validation Manager has become a userful and user-friendly alternative to Airadale’s previous methods for validations and verifications, enabling the team to:
-
Manage the work within a single, structured study
-
Enter data easily from instruments or spreadsheets
-
Generate comprehensive, consistent and customisable reports
The impact is clearest in the most time-consuming parts of the traditional process: data recording and entry, statistical analysis and reporting. Automatically generated reports bring the study data together in one document and can be tailored to show exactly what is needed for review.
These benefits are clearly demonstrated by the TOSOH G11 HbA1c project, which was completed in just one week. One staff member prepared the studies, gathered the data and generated the report. Under the previous approach, this work often involved several staff members, and the team would have needed considerably more time to gather and enter the data, perform the statistical analysis and write the report.
Training and support gave the team confidence in using Validation Manager. Built-in guidance has been very helpful during goal setting and study setup. “Support has been excellent. I contacted support via e-mail a number of times during my initial use of VM and the help I received was excellent and solved my query every time”, said Christopher Claxton, Specialist Biomedical Scientist at Airedale NHS Foundation Trust.
By enabling staff across different grades — not only senior staff — to carry out validation and verification work, Validation Manager gives Airedale greater flexibility to delegate tasks, thus saving valuable staff time and reducing costs.
4 Key outcomes
- One-week end-to-end project. The TOSOH G11 project covered planning, sample analysis, data analysis and review within one week.
- One staff member across the workflow. One person prepared the studies, gathered the data and generated the report for the TOSOH G11 project.
- Less administrative work. The largest gains were in data recording and entry, statistical analysis and report generation.
- Consistent, customisable reporting. Study data can be consolidated in comprehensive reports and tailored to the reviewer’s needs.
- Greater flexibility and efficiency. Staff across different grades can use Validation Manager, allowing Airedale to delegate tasks more flexibly and save valuable staff time.
- A more digital process. The team can carry out validation and verification work without recording results by hand or transferring data between spreadsheets.
