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.
“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.
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Have guidance at your fingertips
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Cut 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.
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Effortlessly filter data to import
If you have dropped large data sets into Validation Manager, you can easily find and filter only the data you want to import with just a few clicks.
Effortlessly filter data to import
If you have dropped large data sets into Validation Manager, you can easily find and filter only the data you want to import with just a few clicks.
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Say goodbye to manual 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 a 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.
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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.
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Easily check raw data graphs
For most qPCR instruments, Validation Manager even enables viewing the raw data graphs of individual samples.
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Save weeks of work 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.
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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.
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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
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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.
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Collaborate painlessly 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.
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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.
And with all information related to the verifications securely stored in one single source of truth, every member in your lab can refer back to it whenever needed.
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.
And with all information related to the verifications securely stored in one single source of truth, every member in your lab can refer back to it whenever needed.
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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.
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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.
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.
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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 database, we handle all personal data with the highest care 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.
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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