Labor Mönchengladbach (Limbach Group) fully automates validations

Read their story

ORGANIZATION TYPE

Medical laboratory

LOCATIONS

Germany

TEST RESULTS PER YEAR

≈ 20 million

DEPARTMENT

MDx

Toxicology

Clinical chemistry

PRODUCT USED

Validation Manager

About

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.

About

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.

“None of Excel-based solutions could provide anything close to the same level of automation, traceability, and ease of use we were looking for.”

André Frontzek, Senior Scientist at Molecular Diagnostics Department, Labor Mönchengladbach

1CHALLENGE

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 which could automate the method validation process and to reduce the manual work needed to manage data and create reports.

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2SOLUTION

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. LIS and instruments of Labor Mönchengladbach to flow to Validation Manager. Features like uncertainty of measurement were implemented to ensure RiliBÄK compliance.

As Validation Manager utilizes CLSI protocols, Labor Mönchengladbach could also rest assure that they fulfil the strictest ISO requirements.

2SOLUTION

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. LIS and instruments of Labor Mönchengladbach to flow to Validation Manager. Features like uncertainty of measurement were implemented to ensure RiliBÄK compliance.

As Validation Manager utilizes CLSI protocols, Labor Mönchengladbach could also rest assure that they fulfil the strictest ISO requirements.

“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.”

Thomas Berche Quality Manager at Labor Mönchengladbach

3RESULT

More validations done, 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 few minutes. This enables them to conduct method validations more frequently than before, with significantly less work.

Wondering how Validation Manager can work for your lab?

Schedule a customized demo with our specialist. We’ll go through your needs, questions, and ways Validation Manager can help boost your verifications.

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