HUSLAB, the leading laboratory service provider nationally in Finland, paves the way for the introduction of new novel diagnostics methods. Evaluation and development of new diagnostics methods is particularly active in the department of clinical microbiology. Commercial test verifications and in-house test validations are a regular activity because of the rapidly evolving landscape, especially in the field of molecular diagnostics.
However, due to the insufficient tools to manage validations according to ever-strictening quality requirements, validation activities have been found extremely burdening and error-prone work. Moreover, validation related work is often fragmented and requires specific knowledge about quality requirements and statistics. Data management has required a lot of manual work and has been handled by using various informal Excel sheets. Furthermore, approaching relocation of the laboratory will require re-validations for all utilized diagnostic tests.
In 2014, Finbiosoft and department of virology and immunology started a collaboration with the aim to introduce a lean and standardized way of conducting validations. The deep needs of users were thoroughly collected, analyzed and a new lean process model was created to streamline validation activities. Validation Manager™ software was introduced into use and verified to address the various needs of users, all the way from validation planning to the data collection, calculation and final reporting of validations.
Implementation of Validation Manager™ yielded substantial benefits for HUSLAB.
Benefits for HUSLAB
- Measured time saving in validations up to 95 %
- Conducting validations is better managed and significantly easier than before
- Regulatory and accreditation requirements can be addressed effectively
- Increased result reliability due to process and data traceability
“Validation Manager significantly streamlines and brings visibility to the validation process.”
Maija Lappalainen, Department head
Clinical microbiology, HUSLAB
The results of the collaboration were published and presented in EMMD 2015 (Poster).
Thanks to the great results achieved, the use of Validation Manager™ was later further expanded to cover the whole HUSLAB laboratory chain with strong emphasis in molecular diagnostics, clinical chemistry, hematology, serology and immunology.
What is HUSLAB?
Leading laboratory service provider in Finland
More than 20 million analyses annually
Follows and applies LEAN principles in lab processes