CHALLENGE: Manual verification and validation processes
SYNLAB Group needed to standardize the quality management across their labs to cope with increasingly demanding quality standards. One core action point was to tackle the time-consuming verification and validation process that required a lot of manual work.
SOLUTION: Automating and standardizing
SYNLAB Group chose Finbiosoft as a partner to together design the standardized digital answer for verification and validation tasks. After the successful pilot, Validation Manager software service was taken into use across SYNLAB Group – to conduct the verifications required e.g. when laboratories change their instrumentation. Validation Manager also allows sharing verification data between laboratories. This standardized, cross-laboratory process saves huge amount of time for laboratory chains like SYNLAB Group and allows new instruments to be taken into use in multiple laboratories sooner, with less resources.
RESULTS: Better quality with less time
With Validation Manager, SYNLAB Group was able to standardize, automate verifications and validations across all their laboratories. “The quality management standardization process was sped up and became more efficient in all aspects. This greatly improved our quality and significantly reduced our workload.” said Dr. med. Petra Lütjens, Head of Quality Management Head at SYNLAB Group.
“On our journey to be an automated and digitalized laboratory, we feel excellently accompanied by the experts at Finbiosoft.”
Dr. med. Petra Lütjens
Head of Quality Management
“We appreciate Finbiosoft’s competent total service which includes not only the Validation Manager software but also consultation to help us optimize our verification and validation processes. Previously, our work was very time-consuming.”
Dr. med. Yvette Ziemendorff
Deputy Medical Director
About SYNLAB Group
- Locations: 40 countries
- Test results per annum: Approx. 500 million
- Implementing Department: Clinical chemistry
Synlab Group is Europe’s largest laboratory service provider. Operating at large scale and at the same time actively acquiring new laboratories, they face challenges in keeping their laboratories’ quality management uniform.
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.
“The actual amount of time saved was higher than the 95% rate mentioned on their product website. Our validation and verification process with the related V&V data is now more comprehensive and better organized than ever before. I would recommend Validation Manager™ to my colleagues so they may see the benefits by themselves.”
“None of Excel-based solutions could provide anything close to the same level of automation, traceability, and ease of use we were looking for.”
Molecular Diagnostics Department
About Labor Mönchengladbach
- Location: Germany (part of Limbach Group)
- Test results per annum: Approx. 20 million
- Implementing Department: MDx, Toxicology, Clinical chemistry
Labor Mönchengladbach is one of the largest, most modern medical laboratories in Germany. While facing the highest quality and efficiency standards, they need to comply with strict regulatory guidelines.
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.
“Validation Manager significantly streamlines and brings visibility to the validation process.”
- Location: Finland
- Test results per annum: Approx. 20 million
- Implementing Department: Clinical microbiology, Clinical chemistry, Hematology
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.