Validation Manager is more than just a tool for validations and verifications. When organizations ponder whether to start using it, they are usually interested in saving time and money. When people start learning to use Validation Manager, we often see that these are not the primary reasons for falling in love with the product. There are other needs related to validations and verifications, and many of them can be solved with Validation Manager and the services built around it. Let’s take a look at how this can be done.
Time-saving, easier data management, and reduced risk of human error
The most prominent pain points in validations and verifications are related to the fact that there’s never enough time to do verifications properly. There’s also frustration related to data management, which may have meant using your evenings copying your measured results to Excel sheets and then your calculated results to Word documents. The risk of human error in these manual steps and errors in calculations in the Excel sheets may distort reported verification results without anyone noticing.
To fix these issues with Validation Manager, there are three things you should make sure of: optimizing data management, setting numerical performance goals, and automating report generation.
Data management
Arrange your data management so that the verification results are exported from the instruments, middleware, or LIS and imported into Validation Manager without any manual editing steps in between. If you continue copying your results to Excel sheets and editing them there, you will lose much of the potential for time savings and traceability, but also for reducing the risk of human error.
Numerical performance goals
Make sure you set performance goals for your verifications. This way, you can easily see on the report whether there’s something that didn’t pass. You don’t need to waste your time checking all the graphs on all the reports, you can concentrate on examining those reports that have issues.
As you probably use the same goals in multiple verifications, you can make it easier to set the goals by starting to use the Quality Module of Validation Manager. You can import your performance goals from a spreadsheet and then just use them on your studies. The centralized goals can now be used in quantitative Comparison, Precision, Quantitative Accuracy, and Linearity studies.
Automated reporting
Make your reporting process as easy as possible. Ideally, you would never need to print out anything. If you write all your conclusions in Validation Manager, you can use Validation Manager to show the accreditors what you’ve done in the verifications. This saves your time and there’s no risk of issues with mixed-up document versions or Excel sheets saved in wrong folders.
We’ve worked with accreditation agencies who are happy to view the verification reports directly in Validation Manager. But if your accreditation agency is not quite so up to date, or if your own processes absolutely require paper documentation, you can still make your final reports such that you can minimize the need for editing them outside Validation Manager. If your report contains mandatory elements that cannot be included as text in your Validation Manager projects, you can have those as separate attachments uploaded into the Validation Manager project. Or if you absolutely need a report that cannot be produced by Validation Manager, have only a summary of your verification as the main report, and include all the details as an attachment produced by Validation Manager.
Standardizing verifications to match the latest guidelines, and understanding the statistics behind them
Sometimes we see laboratories where verifications are done by filling some Excel sheets created decades ago. People might not really understand the meaning of the numbers they need to fill in, and it could be that no one really knows how the reported values are calculated.
In some cases, there are different conventions around the laboratory on how verifications are done. Verifications may even have been outsourced, in some cases to trainees. This makes it very difficult to interpret and compare reports created by different people on different times.
If everyone does their verifications in Validation Manager, that makes it easier for everyone to read the reports others have made, as the way they look like, what they contain, and how the results are calculated is standardized. Quality managers can also define templates. Project templates with references to the SOPs are an easy way to guide the way people do their verifications, and report templates build the printed reports in a standardized way. If needed, you can have a review workflow for your study plans to make sure that the SOPs are followed.
If you feel that you need to understand more about the statistics of verifications, we have good news for you. In our learning portal, we have video courses that introduce the most relevant statistics in a concrete way.
Better tools for collaboration, digital approval workflows
Collaboration in verifications does not need to mean sending Excel sheets by email. In Validation Manager, you can invite other users to collaborate on your project. You can give them full access rights, or you can give them only rights to import result files.
It is also possible to invite people to projects in a reviewer role so that they can check study plans and the finalized projects and accept them.
When the reports are commented, you’ll easily see who has left a comment and when.
Better confidence in quality through improved ability to do V&V, better traceability, and better visibility on how it’s going
Once you learn to use Validation Manager, you can start thinking if you’d like to do more verifications than what you’ve done so far. As verifications stop being such a burden, you can create new habits for monitoring your quality e.g. through periodic instrument comparisons. When introducing new analyzers or assays, you might want to verify some analytes a bit more thoroughly than before, as it’s not so difficult anymore.
As all the verifications are found in one place where you can easily search things based on analyte or analyzer, it’s easier to track the progress of verifications.
Are you reaping all the benefits?
What’s good to understand is that your choices affect how much benefits you get. Sometimes, in the middle of hectic laboratory work, it may feel a bit overwhelming to do this all. And it’s perfectly ok to start by adjusting Validation Manager to your existing processes. But there’s a risk that you’ll get used to that and never take advantage of all the possibilities you have to improve and make your work easier. That’s why, it’s good to assess your situation periodically and ask: what more could you get from Validation Manager?
Accomplish more with less effort
See how Finbiosoft software services can transform the way your laboratory works.
