German laboratories are often part of networked laboratory groups. As laboratory quality standards are increasingly demanding and labs are constantly forced to be more efficient, synergies found in a laboratory group can be vital to guarantee laboratories’ success. However, to get laboratory groups work effectively, it is necessary that all quality processes can be designed, executed and managed in the same way in all of the labs. At the same time, it is crucial to encourage easy exchange of experience and expertise between laboratories.
The Synlab Group, which is one of the largest laboratory groups in Germany, is aiming to standardize its quality management concepts over its all laboratories. One of the most important topics of this project has been the verification and validation process, which has previously been a source of huge amount of manual workload.
In late 2017, the Synlab group had a chance to pilot Validation Manager™ software service at its Leverkusen laboratory. This project made the Synlab Group Quality Management realize the benefits of utilizing Validation Manager™ to standardize and automate verifications and validations of the entire laboratory group.
Dr. med. Petra Lütjens, Head of Quality Management for the Synlab Group, was happy to see that the Validation Manager solution could be used to boost cross-site collaboration and process standardization. After the pilot project, she said,
“In this way, the standardization process currently in progress for quality management can not only be sped up, it can also be made more efficient in every respect by a professionally supported and easily scalable tool. This will greatly improve our quality, and our workload will also be significantly reduced in the future thanks to Validation Manager.”
The findings achieved were exchanged among the quality managers of all the German Synlab sites. At the Leinfelden-Echterdingen laboratory, there was a particularly urgent need due to the upcoming system changes and a multitude of verifications required for the system implementation. Therefore, Validation Manager roll-out work was started promptly also at this laboratory.
Dr. med. Yvette Ziemendorff, Deputy Medical Director for the Leinfelden-Echterdingen laboratory, realized from the first meeting with Validation Manager team that the cooperation with Finbiosoft is not just about implementation of a software tool, but also about consolidating skills in the design of verification and validation processes.
“We are very interested in laying the foundations for the future quality of our laboratories. And our needs are very diverse, because many new innovations in technology and IT are currently gaining importance in the laboratory. Some validations are far from trivial. Therefore, we appreciate the competent total service of Finbiosoft, which includes not only Validation Manager, but also consultation to help us optimize our verification and validation processes. Previously, our work was very time-consuming” stated Dr. med. Ziemendorff.
“In the example of Synlab, we see the current trend of increasing automation and industrialization in the modern laboratories. Together with Synlab, we are designing the standardized digital answer for verification and validation tasks. Only in this way will we be able to deal with the increasing workload required in the large laboratory groups.” states Akseli Virtanen, CEO of Finbiosoft, the company behind the Validation Manager software service. “In laboratory groups, the distance between quality management and the verified instrument becomes often very large. Thus, it is evident that only a fully standardized and automated solution like Validation Manager is working efficiently.” Mr. Virtanen continues.
Within the Synlab Group, there are several main laboratories that exchange and bundle verification and validation tasks with several auxiliary sites within a radius of 50–100 km. With the simultaneous rollouts of new technologies, the benefits of standardized, cross-site validation processing will offer massive time savings. As a result, new laboratory instruments quickly become productive and the QM can support labs without delay. And thanks to Validation Manager, all these
collaborative verifications are now easy to handle.
”On the way to the automated and digitalized laboratory, we feel excellently accompanied in our verifications and validations by the experts at Finbiosoft.”
Dr. med. Petra Lütjens
Head of Quality Management
- One of the five largest clinical laboratory groups in Germany with around 4300 employees
- Part of Synlab Europe, the largest laboratory chain in Europe
- More than 20,000 employees and approximately 500 million test results annually in Europe
Fully automated validations for clinical chemistry and molecular diagnostics
German laboratory diagnostics face the most demanding conditions worldwide concerning quality and efficiency. To achieve cost efficiency and the best possible competitive advantage, together with compliance with the regulatory requirements, it is necessary that method validations and verifications integrate well in the quality management process, and that they support high automation.
Labor Mönchengladbach, MVZ Dr.Stein + Kollegen, which is part of the nation-wide Limbach group, is one of largest and most modern medical laboratories in Germany. In 2017, this forerunner laboratory adopted Validation Manager™ with a goal of automating and digitalizing their method validation needs throughout the organization.
Thomas Berche, Quality Manager at MVZ Dr.Stein + Kollegen, explains the background of their needs. “Obtaining the highest quality is essential in all operations of our organization. We strictly follow the national RiliBÄK guidelines, and all our areas are accredited by DAkkS (Germany’s national accreditation body) according to DIN EN ISO 15189:2014.”
“Also, the lab relocation in spring 2016 and introducing one of the largest automated laboratory systems by Roche in Europe really challenged our capabilities to ensure the quality assurance activities required. We needed to find a solution that would automate the method validation process and reduce the manual hands-on work that was wasted on various data management and reporting steps,” Berche continues.
“After thorough evaluation of the options, it became obvious that the Validation Manager™ solution, provided by Finbiosoft, stood in a class of its own,” says Berche.
“None of the Excel-based solutions could provide anything near the same level of automation, traceability and ease of use we were looking for.”
André Frontzek, Senior Scientist from the Molecular Diagnostics department agrees with Berche: “We wanted to obtain a solution for the future and to follow our dream of a paperless laboratory. After my first encounter with Validation Manager™, I knew that I had found the right solution for us. None of the Excel-based solutions could provide anything near the same level of automation, traceability and ease of use we were looking for.”
During the early spring of 2017, Validation Manager™ was taken into use in close collaboration between the organizations. Customer requirements were mapped, analyzed, and required functionalities, such as supporting data transfer from the LIS, measurement uncertainty and total analytical error, were implemented.
“I must admit that I am very impressed with the forward-looking attitude of the people at MVZ Dr.Stein + Kollegen,” says Akseli Virtanen, R&D Director at Finbiosoft. “Introducing the very latest CLSI-based V&V protocols, fulfilling the national RiliBÄK requirements and other industry-leading ISO requirements has been a challenging but a rewarding journey. I especially value the close professional dialog and the feedback loop between the people we have had right from the beginning of the project,” Virtanen adds.
“I would say that Finbiosoft should think about increasing the 95% time saving rate on their product website.”
Berche expresses his satisfaction with the results obtained from the collaboration. “I am very pleased with the type of workflow that Validation Manager™ has enabled us to perform. In just a few minutes I can carry out a complete verification analysis and create corresponding documentation in parallel for thousands of samples from multiple instruments and hundreds of individual analytes. This enables me to conduct method validations more frequently than before, with significantly less work. I would say that Finbiosoft should think about increasing the 95% time saving rate on their product website. Of course, there are always a few things that could be improved, but it is not a problem since our requirements are heard and implemented really quickly,” says Berche.
“I would be happy to recommend Validation Manager™ to my colleagues so that they may see the benefits by themselves.”
During summer 2017, after streamlining and fine-tuning the organization-wide validation process, the rest of the users, such as technicians running the V&V samples, have been trained. The next focus for Berche will be managing the DAkkS re-accreditation in November 2017. “I can sleep well and confidently wait for the upcoming re-accreditation, after knowing that our validation and verification process with the related V&V data is now more comprehensive and better organized than ever before. I would be happy to recommend Validation Manager™ to my colleagues so that they may see the benefits by themselves.”
What is MVZ Dr.Stein + Kollegen?
- Highly advanced, private service lab located in Mönchengladbach, Germany
- Part of the Limbach Group, one of the largest laboratory chains in Germany
- More than 600 employees and approximately 20 million conducted tests annually
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