ORGANIZATION TYPE
Medical laboratory
From fragmented to unified: How Cork University Hospital lab streamlined verifications amid relocation
Read their story
LOCATION
Ireland
DEPARTMENTS
All laboratory disciplines (Biochemistry, Haematology, Microbiology, Histopathology, Transfusion Medicine) and Point of Care testing
PRODUCT USED
Validation Manager
About
Cork University Hospital (CUH) is the statutory acute hospital provider for Cork, Ireland’s largest county and second largest city. With over 5000 staff, it is the primary teaching hospital for University College Cork and the leading centre in Ireland for clinical placements and research trials.
About
Cork University Hospital (CUH) is the statutory acute hospital provider for Cork, Ireland’s largest county and second largest city. With over 5000 staff, it is the primary teaching hospital for University College Cork and the leading centre in Ireland for clinical placements and research trials.
“[With Validation Manager], there were no studies that we were unable to perform. Also once the data is loaded, it is very useful to be able to compare results across analysers which was something we had not previously done.”
Alison Bransfield, Principal Clinical Biochemist, Cork University Hospital
1 CHALLENGE
Lab relocation sparked need for unified verification workflow
As part of a major transition, the biochemistry and haematology laboratories relocated to a new blood sciences facility. This required not only the acquisition of new analysers but also comprehensive verifications and validations against the old equipment.
Previously, verification and validation work had been carried out using a variety of tools such as R, Excel, Analyse IT, and MedCalc, depending on individual preferences. This fragmented approach made it difficult to maintain consistency, transparency, and efficiency across projects. The team needed a unified solution to simplify their workflow while also meeting accreditation standards.
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2SOLUTION
One platform for all verification and validation needs
The lab adopted Validation Manager as their all-in-one platform for verifications and validations. All aspects of the verification process — from study design and data import to analysis, review, and final sign-off — are now completed within Validation Manager.
Key benefits
- Agility: Validation Manager allows the lab to independently add new instruments and tests without external support, offering valuable flexibility as operations evolved.
- Standardization: The ability to create and reuse project templates ensures that all projects are carried out in a consistent manner.
- Comprehensive study selection: While only quantitative studies are used in biochemistry, the broad range of available studies fully meets the team’s needs. “There were no analyses the team was unable to perform”, said Alison Bransfield, Principal Clinical Biochemist at Cork University Hospital.
- Effortless data handling: Data was easily imported via CSV files from middleware and Excel sheets. “Once the data is imported there is never a need to perform manual interventions, so this ensures that data is not inadvertently changed,” Alison added.
- Traceability: The comprehensive audit trail allows the lab to to see all interventions, when they were performed and by whom.
- Automatically generated reports: Validation Manager automatically generates detailed reports as soon as data is imported.“Once the data was loaded, the ability to compare results across analysers proved especially useful, providing a level ofinsight that hadn’t been possible with previous methods”, Alison stated.
- Easy accreditation: The lab prints a hard copy summary report for change control, while the full, detailed report is securely stored within Validation Manager. If any follow-up questions arise or additional data analysis is required, the team can easily revisit the project and perform further work.
- Outstanding Customer Support and Training: The lab gets quick responses whenever they need tips on using Validation Manager or want to suggest improvements. The training sessions were also useful, making it easy to get up to speed.
- Built-in guidance: The guidance inside Validation Manager serves as a good teaching tool for explaining the underlying statistical practices. Plus, it points to the right CLSI guidelines, which is super handy.
2RESULT
One platform for all verification and validation needs
The lab adopted Validation Manager as their all-in-one platform for verifications and validations. All aspects of the verification process — from study design and data import to analysis, review, and final sign-off — are now completed within Validation Manager.
Key benefits
- Agility: Validation Manager allows the lab to independently add new instruments and tests without external support, offering valuable flexibility as operations evolved.
- Standardization: The ability to create and reuse project templates ensures that all projects are carried out in a consistent manner.
- Comprehensive study selection: While only quantitative studies are used in biochemistry, the broad range of available studies fully meets the team’s needs. “There were no analyses the team was unable to perform”, said Alison Bransfield, Principal Clinical Biochemist at Cork University Hospital.
- Effortless data handling: Data was easily imported via CSV files from middleware and Excel sheets. “Once the data is imported there is never a need to perform manual interventions, so this ensures that data is not inadvertently changed,” Alison added.
- Traceability: The comprehensive audit trail allows the lab to to see all interventions, when they were performed and by whom.
- Automatically generated reports: Validation Manager automatically generates detailed reports as soon as data is imported.“Once the data was loaded, the ability to compare results across analysers proved especially useful, providing a level ofinsight that hadn’t been possible with previous methods”, Alison stated.
- Easy accreditation: The lab prints a hard copy summary report for change control, while the full, detailed report is securely stored within Validation Manager. If any follow-up questions arise or additional data analysis is required, the team can easily revisit the project and perform further work.
- Outstanding Customer Support and Training: The lab gets quick responses whenever they need tips on using Validation Manager or want to suggest improvements. The training sessions were also useful, making it easy to get up to speed.
- Built-in guidance: The guidance inside Validation Manager serves as a good teaching tool for explaining the underlying statistical practices. Plus, it points to the right CLSI guidelines, which is super handy.
“The support is the number one aspect, it is outstanding. The software is user friendly and the use of project template sensures that all projects are carried out in a consistent manner. I would recommend Validation Manager without hesitation—and I already have.”
Alison Bransfield, Principal Clinical Biochemist, Cork University Hospital
3RESULT
Streamlined process, substantial time savings, and stronger accreditation readiness
The lab cut down verification time substantially with Validation Manager.
While data handling wasn’t the biggest bottleneck, the entire process became much more streamlined. Additionally, the verification reports have been positively received by the accreditation body.
While the learning curve was initially steep, once the users became familiar with the platform, Validation Manager became intuitive and efficient to use.
Looking ahead, Validation Manager will continue to be used for all verifications and validations. Additionally, the biochemistry team plans to use it for monthly and quarterly reviews of internal quality control results.
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