HUSLAB achieves LEAN validations with Validation Manager

Read their story

ORGANIZATION TYPE

Medical laboratory

LOCATION

Finland

ANALYSES PER YEAR

≈ 20 million

DEPARTMENT

Clinical microbiology

Clinical chemistry

Hematology

PRODUCT USED

Validation Manager

About

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.

“Validation Manager significantly streamlines and brings visibility to the validation process.”

Maija Lappalainen, Department Head, Clinical Microbiology, HUSLAB

1CHALLENGE

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.

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2SOLUTION

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.

3RESULT

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 in EMMD international congress.

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