For Clinical Labs
In today’s diagnostic landscape, laboratories must deliver fast, reliable, and cost-effective results despite staffing shortages, tighter regulations, and rising technical complexity.
HUSLAB achieves LEAN validations with Validation Manager
About Huslab
HUSLAB is a leading laboratory service provider in Finland, paving the way for novel diagnostics methods. While in-house test validations of the diagnostics methods took place frequently, they were found to be extremely burdensome and error-prone.
1 Challenge
Burdensome and error-prone validations
HUSLAB’s top challenges were the lack of tools to manage validations according to ever-stringent quality requirements, fragmented processes, and insufficient knowledge of changing quality requirements and statistics. Their data management required a lot of manual work and was handled by informal Excel sheets. In addition, the approaching laboratory relocation would require re-verifications for all utilized diagnostic tests.
2 The solution
A LEAN approach
HUSLAB’s virology and immunology departments started collaborating with Finbiosoft to create a new lean model to streamline validation activities. Validation Manager software was put to work to address various needs from validation planning, data collection and calculation to final reporting of validations.
3 The result
Streamlined and visible validations
The implementation of Validation Manager yielded substantial benefits for HUSLAB – up to 95% validation data management time saved; better-managed and significantly easier validations; all regulatory and accreditation requirements effectively addressed; and improved result reliability due to process and data traceability.
This collaboration success expanded the use of Validation Manager across all HUSLAB laboratories, especially in molecular diagnostics, clinical chemistry, and hematology. The collaboration results were also presented at the EMMD international congress.
