Say goodbye to exhausting verifications

Validation Manager is a cloud-based software service that automates the verifications and validations of laboratory methods and instruments. It has been developed for over a decade together with laboratories around the world. Our customers have measured that even 95 % of the time previously wasted can be removed with Validation Manager. What is most important, however, is the leap in quality that can be reached with a new mindset and new software solutions.

Validation Manager use cases range from verifications and validations to routine quality control of the laboratory. Furthermore, test manufacturers can empower their customers to conduct faster verifications of their instruments, and even conduct troubleshooting activities remotely. Laboratory groups can achieve full benefits of centralization and standardization by collecting quality data from all laboratories into one centralized platform.

Labor Mönchengladbach has totally automated their laboratory’s quality control with Validation Manager.

SYNLAB Group uses Validation Manager to standardize and automate verifications across their laboratories.

Siemens Healthineers benefits from using Validation Manager. See how your organization can, too.

Laboratories and test manufacturers of every size trust Validation Manager

“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 at Leinfelden-Echterdingen laboratory

Enabling four major changes in your laboratory

Digitalized

Speed up verifications and validations by taking the manual work out of your workflow. No more messy spreadsheets, manual data analysis, or tedious report creation.

Automated

Stop transcribing data manually into spreadsheets. Transfer it from your instruments, middleware, LIS, or spreadsheet files into Validation Manager with just a few clicks.

Standardized

Leave no room for subjective approaches and misinterpretation. Rest assured that all workflow steps are done in the same way. 100% comparable results regardless of the creators.

Centralized

No more hunting for information across your organization. Gather it all in one place for easy organizational access and keep everyone working on the same goals.

Software service for all types of laboratories and test manufacturers

Medical laboratories

Conduct truly lean verifications:

Have everyone follow the same protocols and processes. Use standardized reporting templates for easy accreditations.

Save weeks of time by automating data transfer and reporting, so you can spend more energy on improving the quality and operations of your laboratory.

Gain unprecedented insights into your laboratory performance. Validation Manager can hold all of your results for easy tracking and analysis.

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Laboratory groups

Centralize quality management:

Align all your laboratories around the common quality management standards and workflows.

Effortlessly conduct centrally managed verifications, saving samples, reagents and time.

Create verification templates and common performance goals for all laboratories.

Compare achieved performance metrics within and between the units.

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Test manufacturers

Speed up the instrument implementation process:

Provide Validation Manager to your customers together with your instruments, so they can verify new instruments 6x faster than before. This means faster implementation of your instruments into routine and faster reagent sales.

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How it works

All validations and verifications done in Validation Manager will be organized as projects. Each project contains a number of studies, each of which is aimed at establishing or verifying one or multiple performance characteristics. All studies have their own protocols, which are executed using a standard workflow with three steps.

Step 1: Plan

Have a plan drawn up so you can define verification objectives and study scope. Validation Manager doesn’t force you to work in a certain way, but you can choose the scope of the protocol used.

Step 2: Work

Perform the actual measurements in your laboratory, then effortlessly transfer the results to Validation Manager using our flexible data importing methods.

Step 3: Report

Watch your results turned to insightful graphs and performance metrics in a snap. Add your own comments and remarks and let Validation Manager generate the final report for you.

How to import data into Validation Manager

Your data, your way. Choose from four flexible options to import your data.

1. Instrument files

In case your instruments are not connected to middleware or LIS, it is good to know that the results can be transferred automatically using the instrument export files.

We have already built support for dozens of instruments, ranging from clinical chemistry automates to qPCR, and we are constantly adding more. Find out if yours is already on the list.

2. Middleware

When multiple instruments are connected to the same middleware, you can import results for all of them at once. This way you can, for example, complete instrument comparisons within minutes.

Validation Manager supports most common middleware software products, and we are constantly adding more.

3. LIS

Laboratory information system is a great source for verification data, as most of the instruments are transferring all result data automatically there.

With one import from LIS, you can complete very large verifications or review even months worth of QC data and evaluate e.g. measurement uncertainty.

4. Excel or .CSV

If none of the other ways is possible, or you have existing data you want to use, then the results can also be transferred from Excel or other spreadsheet files.

Validation Manager is flexible in the format and lets you define how to interpret the data on the spreadsheet files. Simply copy paste your data to get your verifications completed.

Regulation compatibility

Validation Manager has been developed to meet the requirements of ISO 15189, ISO 17025, and the new IVDR.

These standards only tell you what to do but not how to do it, so the actual work in Validation Manager is then based on the latest, internationally recommended protocols, calculation methods and reporting.

As Validation Manager has been used around Europe for many years, the verification reports are widely accepted in accreditations by different organizations such as DAkkS, FINAS, UKAS, and more.

“The actual amount of time saved was higher than 95%. Our validation and verification process is now more comprehensive and better organized than ever before.”

Thomas Berche

Quality Manager

What makes Validation Manager so different?

Data security

It is our primary concern that your valuable data stays safe. Validation Manager is audited and certified by an independent auditor against the latest and most demanding requirements of the industry.

Regulatory compliance

Validation Manager has been used in ISO 15189 and ISO 17025 accredited laboratories across Europe for years. Data and reports generated by Validation Manager have been accepted by all important accreditation services.

Data input/integration

Verification results can be imported directly from instruments, middleware or LIS systems, saving up to 95% of the time previously used to manually transfer data.

Applicability/departments

Whether you are working in automation laboratory or creating your own molecular diagnostics, we have you covered. Validation Manager is easily implementable regardless of the department you work in.

Easy implementation and IT approval

With no need to install local applications, servers or holes in firewalls, Validation Manager can be immediately taken into use.

World-class support

There are times when you simply don’t know or remember how to best continue working with Validation Manager. Rest assured, our friendly and capable support team is always ready to give you a helping hand. Customer feedback is very important to us. Actually so important, that most of the new features we release are entirely based on our customers’ wishes.

Working together online

Cloud-based solution means that you are no longer locked to your work desk. Plan, execute, review and accept studies wherever you are. Share data with your peers and ask them to join improving your laboratory’s quality.

Consultation and training

Rather than just giving you access to Validation Manager, we also want to make sure that your quality processes are top notch and lean. We make sure that Validation Manager adapts to your needs and not the other way around.

Accreditation approved reports at your fingertips

Rather than creating verification reports manually in excel and word, let Validation Manager automatically collect all necessary data into one report based on your organization’s document template. And naturally, all that is ready for accreditation.

“I trust these results much more than our current Excel sheets as the traceability is so good.”

Maija Lappalainen

Department Head, Clinical Microbiology

Learn how real laboratories get real results with Validation Manager

Bedfordshire Hospitals NHS Foundation Trust simplifies validations and verifications

  • Industry: Medical laboratory
  • Departments: Biochemistry, hematology, microbiology, point of care
  • Product: Validation Manager

SYNLAB Group standardizes quality throughout the lab chain

  • Industry: Laboratory group
  • Departments: Clinical chemistry
  • Product: Validation Manager

Labor Mönchengladbach (Limbach Group) fully automates validations

  • Industry: Medical laboratory
  • Departments: MDx, toxicology, clinical chemistry
  • Product: Validation Manager

HUSLAB achieves LEAN validations with Validation Manager

  • Industry: Medical laboratory
  • Departments: Clinical microbiology, clinical chemistry, hematology
  • Product: Validation Manager

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 quality.

Request a demo