CHALLENGE: Quality assurance for relocation and new instruments

Labor Mönchengladbach faced challenges in ensuring the required quality assurance as they relocated their laboratory and introduced a huge clinical chemistry automation line. They needed a solution that could automate the method validation process and to reduce the manual work needed to manage data and create reports.

SOLUTION: Automated validations for clinical chemistry and MDx

Labor Mönchengladbach used Validation Manager to fully automate and digitalize the method validations across their organization. Finbiosoft built solutions to get data from different sources – e.g. from LIS and instruments – of Labor Mönchengladbach to flow to Validation Manager. Features like uncertainty of measurement was implemented to ensure RiliBÄK compliance. As Validation Manager utilizes CLSI protocols, Labor Mönchengladbach could also rest assure that they fulfill the strictest ISO requirements.

RESULTS: More validations with less work

With Validation Manager, their Quality Manager could now do a complete verification analysis and in parallel create corresponding documentation for thousands of samples and hundreds of analytes in just a few minutes. This enables them to conduct method validations more frequently than before, with significantly less work.

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 were handled by informal Excel sheets. In addition, the approaching laboratory relocation would require re-verifications for all utilized diagnostic tests.

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.

RESULTS: 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.