Verify your new instruments in days, not weeks

It’s complex and tedious for clinical labs to implement new instruments. Let Validation Manager handle all the time-consuming manual work, so you can focus on the more important tasks like interpreting your results.

Learn more

“Validation Manager helped our biochemistry department cut the time required to complete instrument verification projects by 30-40%.”

Martyn McAdam

Blood Science Service Manager

Problems with the traditional approach

For years, labs have relied on spreadsheets to verify new instruments. This results in time-consuming and tedious processes that require the entire laboratory staff’s involvement. With Validation Manager, you can automate instrument verifications and say goodbye to the notorious problems of the traditional approach.

Slow

Projects take weeks or months to complete. The more instruments to verify, the longer it takes.

Complex

Each project contain up to hundreds of spreadsheets, with a plethora of data to manage and verifications to run.

Costly

The manual workflows require extensive effort and are prone to human mistakes.

Risky

Labs risk not putting the new instruments into use on time when the projects are late.

“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

The fastest way to verify your new instruments

Validation Manager software service enables your lab to automate instrument verifications, so you can:

Verify new instruments up to 6x faster than with Excel

Spend 95% less time on manual data entry, calculations and reporting

Cut 20% routine quality work

Eliminate human errors

Effortlessly verify tests and instruments within or across labs

Focus on result interpretation rather than manual work

Effortlessly stay compliant with the latest protocols and guidelines, such as ISO 15189, ISO 17025, and the new IVDR

“Validation Manager enables us to produce valid verification/validation reports without the need for advanced math statistics knowledge. Now, our validation/verification process can be completed by most staff levels.”

Ana Teles

Clinical Biochemistry Section Lead

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.

Feature 1/7

Have guidance at your fingertips

Click to enlarge

Get step-by-step instructions

When starting new instrument verification projects, you don’t have to hunt for guidance on what to do and how. Validation Manager provides all the information you need and guides you through each step.

Get step-by-step instructions

When starting new instrument verification projects, you don’t have to hunt for guidance on what to do and how. Validation Manager provides all the information you need and guides you through each step.

Click to enlarge

Breeze through workflows

Validation Manager has workflows curated for a vast array of qualitative and quantitative studies. These workflows are designed to guide you through all the elements needed to carry out verifications that are statistically relevant and compliant with the latest protocols and guidelines.

Click to enlarge

Click to enlarge

Guide your colleagues with project templates

Build your lab’s own verification project templates with pre-defined sets of studies and detailed instructions on how to complete each study plan. This makes guiding your colleagues easy and ensures that everyone follows your lab’s standardized internal processes.

Guide your colleagues with project templates

Build your lab’s own verification project templates with pre-defined sets of studies and detailed instructions on how to complete each study plan. This makes guiding your colleagues easy and ensures that everyone follows your lab’s standardized internal processes.

Click to enlarge

Put your report templates to work

Upload your lab’s own report templates with pre-approved layouts, so all reports generated will be standardized and reliable. The outcome? Easy accreditations.

Click to enlarge

Click to enlarge

Unlock your productivity

Reuse protocols and goals from existing study plans to complete new projects even faster, with minimal manual effort.

Unlock your productivity

Reuse protocols and goals from existing study plans to complete new projects even faster, with minimal manual effort.

Click to enlarge

Feature 2/7

Plan your studies in minutes

Simply fill in the blanks

Validation Manager guides you through the planning process, so you don’t have to figure it out on your own. Just fill in the plan step by step and you’ll get a steady verification plan in minutes. Even better, Validation Manager always asks you to set performance goals for your studies at this phase—before any results are produced. This ensures that everyone’s analysis is objective and transparent, and all results are easily comparable.

Click to enlarge

Click to enlarge

Run many verifications simultaneously

What also makes Validation Manager unique is it enables you to do multiple different verifications within one study. This makes managing your data and results easier as you don’t have to manually work through dozens of individual Excel sheets.

Run many verifications simultaneously

What also makes Validation Manager unique is it enables you to do multiple different verifications within one study. This makes managing your data and results easier as you don’t have to manually work through dozens of individual Excel sheets.

Click to enlarge

Feature 3/7

Save weeks of manual data entry with automated data import

Simply drag and drop data files

Instead of manually transcribing your data into dozens of individual Excel sheets, you can save weeks of work by dragging and dropping all data files into Validation Manager at once.

The data files can be grabbed directly from your laboratory instruments, middleware, or LIS. This makes your process efficient as you don’t have to deal with any Excel work or manual data input. You can also import Excel sheets into Validation Manager if your data is already there.

Validation Manager accepts data files from all major instruments, middleware, and LIS products used by labs and we’re constantly adding more.

Click to enlarge

Click to enlarge

Click to select data to import

Once you’ve dropped the files into Validation Manager, you can effortlessly select specific data you want to import (e.g. from which tests and instruments, for which samples) in just a few clicks.

Click to select data to import

Once you’ve dropped the files into Validation Manager, you can effortlessly select specific data you want to import (e.g. from which tests and instruments, for which samples) in just a few clicks.

Click to enlarge

Feature 4/7

Save up to weeks with automated result analysis

Go from raw data to calculated results in seconds

Once you have completed importing data, Validation Manager instantly calculates all of the results based on the latest protocols and guidelines. The calculated results are automatically marked as passed or failed based on your performance goals. This way, you don’t have to manually make conclusion for each of them and can simply review those that actually need your attention. Even better, all results in Validation Manager are calculated with 95% confidence intervals, so you can easily evaluate their reliability without having to know advanced statistics.

Click to enlarge

Click to enlarge

Get everything you need without breaking a sweat

Validation Manager also creates all necessary graphs for you in seconds. You’ll no longer have to deal with loads of Excel work. What’s more, Validation Manager makes it easy to check how concordant your new results are with the old ones. You can even monitor this for each medical decision point separately.

Get everything you need without breaking a sweat

Validation Manager also creates all necessary graphs for you in seconds. You’ll no longer have to deal with loads of Excel work. What’s more, Validation Manager makes it easy to check how concordant your new results are with the old ones. You can even monitor this for each medical decision point separately.

Click to enlarge

Easily check raw data graphs

For most qPCR instruments, Validation Manager even enables viewing the raw data graphs of individual samples.

Click to enlarge

Feature 5/7

Save up to weeks with automated reporting

Get an instant overview of all your reports

With Validation Manager, you no longer have to juggle verification reports from dozens of Excel sheets as Validation Manager gives you an overview of all your reports. You can simply click on any of them to see more details, including all the relevant graphs, results, and comments.

Click to enlarge

Click to enlarge

Produce the final report in one click

You also don’t have to waste time building the final verification reports as Validation Manager produces a ready-to-download Word report for you in one click. All you need to do is select what to include. No more copy/pasting every detail as with the conventional approach.

What’s even better is you can go fully digital and ditch all the paper, Word, and Excel work. Rather than printing the Word reports out, just show the accreditors your results and all relevant information right inside Validation Manager.

Validation Manager has been used in ISO 15189 and ISO 17025 accredited laboratories across Europe for years, so the data and reports it generates have been accepted by all important accreditation services.

Produce the final report in one click

You also don’t have to waste time building the final verification reports as Validation Manager produces a ready-to-download Word report for you in one click. All you need to do is select what to include. No more copy/pasting every detail as with the conventional approach.

What’s even better is you can go fully digital and ditch all the paper, Word, and Excel work. Rather than printing the Word reports out, just show the accreditors your results and all relevant information right inside Validation Manager.

Validation Manager has been used in ISO 15189 and ISO 17025 accredited laboratories across Europe for years, so the data and reports it generates have been accepted by all important accreditation services.

Click to enlarge

Feature 6/7

Get full traceability of all your results

Effortlessly trace any result back to the raw data

Validation Manager gives you full traceability of all results, so you can click on any of them to see:

  • your original data and where it came from

  • who has done what and when

  • all relevant sample and instrument details

Click to enlarge

Click to enlarge

Never lose track of outliers or errorness of results

What makes Validation Manager unique is that it automatically recognizes potential outliers and gives you a standardized way to mark them as such. For results that need to be removed due to non-statistical reasons, Validation Manager gives you the option to exclude them from the analysis. These results will, however, not be deleted from the reports but remain fully traceable as the rest. You can always click on them to see who has carried out the action, when, and with what comment. This way, you’re ready to answer any questions from accreditors as all relevant information is accessible in one click.

What’s more, you don’t need to worry about re-calculating the results as Validation Manager does that automatically as soon as any data point has been marked as outlier or excluded.

Never lose track of outliers or errorness of results

What makes Validation Manager unique is that it automatically recognizes potential outliers and gives you a standardized way to mark them as such. For results that need to be removed due to non-statistical reasons, Validation Manager gives you the option to exclude them from the analysis. These results will, however, not be deleted from the reports but remain fully traceable as the rest. You can always click on them to see who has carried out the action, when, and with what comment. This way, you’re ready to answer any questions from accreditors as all relevant information is accessible in one click.

What’s more, you don’t need to worry about re-calculating the results as Validation Manager does that automatically as soon as any data point has been marked as outlier or excluded.

Click to enlarge

Feature 7/7

Collaborate seamlessly on every verification project

Have all comments gathered in one place

No more hunting for scattered comments or sending endless emails back and forth. Each report has a dedicated comment field located directly where your results are, so everyone can write remarks, add important information, and ask questions in one place. This standardizes and simplifies your feedback loop.

Click to enlarge

Click to enlarge

Get full visibility into every project

You can easily track the life cycle of every project, including those your colleagues are working on. With all results, conclusions and other details visible in real-time, you’ll never have to wait until a project is completed to know what has happened. Even better, you can work on studies and projects at the same time with your colleagues.

Get full visibility into every project

You can easily track the life cycle of every project, including those your colleagues are working on. With all results, conclusions and other details visible in real-time, you’ll never have to wait until a project is completed to know what has happened. Even better, you can work on studies and projects at the same time with your colleagues.

Click to enlarge

Always stay in sync with your colleagues

All project components are shown in a standardized format, so you can easily understand, review, continue from, or take on your colleagues’ tasks when needed. New team members can also catch up fast without vigorous onboarding.

Click to enlarge

Click to enlarge

Have a single source of truth

Validation Manager enables your lab to create, carry out, and organize all verification projects in one place. All information related to the verifications is securely stored in one single source of truth that every team member can refer back to whenever needed.

Have a single source of truth

Validation Manager enables your lab to create, carry out, and organize all verification projects in one place. All information related to the verifications is securely stored in one single source of truth that every team member can refer back to whenever needed.

Click to enlarge

Work anywhere

You don’t have to be at the office to get work done. As Validation Manager is a cloud-based solution, you can work anywhere with a computer and the internet.

Click to enlarge

Enterprise-grade data security

External validation

Validation Manager is audited and certified by an independent auditor for large scale software development information security practices, according to OWASP Application Security Verification Standard (OWASP ASVS).

GDPR

Although there is no patient data ever stored into Validation Manager’s system, we take the highest caution on handling personal data and are always very open about our practices. We are committed to helping our customers and users understand and comply with the General Data Protection Regulation (GDPR).

Data encryption

All data in Finbiosoft Cloud, whether in transit or at rest, is encrypted.

Regional data residency

Validation Manager services are run and data stored in data centers located inside EU.

Authentication

All access to Validation Manager is controlled and all logins are audited. Furthermore, actions and changes inside Validation Manager are audited based on the user logged in. Validation Manager provides support for single sign-on (Microsoft Login), two-factor authentication, as well as user roles and permissions to ensure that the right team members have the right level of access to different functionality.

FAQ

What happens after my lab purchase Validation Manager?

As a Validation Manager customer, you don’t just get the software but also receive a comprehensive onboarding process to help you get started easily. In short, the onboarding process include three phases:

  • The kick-off phase, where we ensure that we are on the same page on how you’ll start using Validation Manager and what needs to be done to make it easy. We will also set up your Validation Manager so that it’s ready for your verifications.

  • The training phase, where we ensure that you know how to get your first verifications done in Validation Manager.

  • The check-up phase, where we help you get more out of Validation Manager.

The idea is to get forward in sessions that are small enough for your time management. You’ll learn things that you can use right now in your work. And you also get concrete help in getting your job done.

Learn more about Validation Manager’s comprehensive onboarding process here.

What kind of customer support do you provide?

Validation Manager customers can get help from our support specialists by:

  • sending email to [email protected]
  • sending support tickets using the chat feature in Validation Manager

We also provide a Support Portal (available 24/7 for our customers) with self-help resources including:

  • service manual and user instructions, statistical handbook
  • release notes about the updates made

What else can my lab use Validation Manager for besides to verify new instruments?

Labs can use Validation Manager for both large projects such as the introduction of new instrumentation following a tender and for all the many smaller verification that are constantly ongoing such as measurement of uncertainty, lot-to-lot or calibration variation, precision, and comparisons.

Which laboratory disciplines can use Validation Manager?

Validation Manager can be implemented into a wide variety of disciplines/specialties such as Clinical Chemistry, Haematology, Coagulation, Immunology, Immunochemistry, Molecular and Microbiology labs/departments, and more.

Why is Validation Manager cloud-based?

Cloud-based software is all about providing an uninterrupted, reliable service and making information security a major focus. By providing Validation Manager as a cloud-based solution, we ensure that our customers can enjoy a comprehensive, high-performance solution with a low total cost of ownership—all while keeping their data safe, their interactions secure, and their businesses protected.

As Validation Manager is cloud-based, it doesn’t need to be installed anywhere and can be run on an internet browser. Your lab’s IT department doesn’t need to manage the service on your own servers. We take care of everything from deployment to backups, security and so on.

Why would investing in Validation Manager make sense for my lab?

Excellent question. Validation Manager is a new way for your lab to conduct verifications. Unlike the traditional approach that strongly relies on Excel spreadsheets, Validation Manager enables your lab to automate, digitalize, standardize and centralize your verifications. The bottomline? Your lab can:

  • achieve financial gains and make financial savings through increased efficiency
  • increase diagnostic quality with less effort

Read up on how Validation Manager can help you get your verifications done faster, with less effort.

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.

Request a demo