How to take Validation Manager into use?

Validation Manager makes verifications easy. Yet, for some people, it may seem like an overwhelming task to start using it.

Nevertheless, we are confident that shaping up your verifications doesn’t need to be difficult. Follow these steps to finally get rid of Excel spreadsheets and make your verifications run smoothly.

Getting forward step by step

To be honest, Validation Manager is rarely a plug-and-play solution. Laboratories have different conventions and processes in regards to their verifications, as well as different ways of data management in general. That’s why their expectations differ when they start using Validation Manager.

Also, it is common that the people responsible for verifications are very busy. They feel that they do not have enough time to do their work well, let alone learn to use a new tool. If you are already using your nights and weekends to get the necessary verifications done, how would you have the capacity to learn to do it in a new way?

To tackle these obstacles, we’ve created a step-by-step process to get you on board. In short, there are three phases where we guide you and make sure that you can get started easily:

• The kick-off, where we make sure 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 and make sure that it’s ready for your verifications.

• The training, where we make sure that you know how you can get your first verifications done in Validation Manager.

• The check-up, 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.

By reading this article, you will get an idea of what to expect after the purchase decision.

The kick-off phase

During the first phase, we will make sure that we have all the required information to set up your Validation Manager for you and to plan the training that fits your needs. We also want you to get more familiar with the product so that you know where we’re heading. Depending on your needs, we may discuss things like verification protocols and processes, currently used templates and report formats, data transfer, and upcoming verification projects.

For things to run smoothly, you should do a couple of things before the actual kick-off meeting.

How to prepare for the kick-off meeting

Before the kick-off meeting, we’d ask you to send us a few things:

• A list of your tests and instruments relevant to the upcoming verification projects, including reference instruments and tests. You will get an Excel template to fill with this information. In the meeting, we’ll make sure that we understand what the list contains. That way, we’ll know how to set up this information into your Validation Manager so that it’s easy for you to start using it.

• Some examples of your existing verification data and reports, e.g., for method comparison and/or precision. This helps us plan the product introduction and training to your needs. We also like to use your own data while giving a demo of the product. That seems to make it easier for people to concentrate on relevant things and to understand what Validation Manager is all about.

• Example data files from those instruments or middleware or LIS that you want to use in the first verifications. This is because often, there are differences in device configurations that affect how the data files should be interpreted.

It would be best if you could send us everything a couple of days before the kick-off. We need some time to go through them to plan the kick-off meeting efficiently so that you will get the most out of it.

Who should participate the kick-off?

People who are responsible for the verifications should attend the kick-off. If someone else is responsible for choices like which verification protocols to use or how to get the verification data to Validation Manager without typing numbers manually into Excel sheets, they should also be present. It is important that, during the kick-off, we can make decisions on how to proceed with verifications.

At the same time, it would be good if only a small number of people attend the kick-off. A good kick-off has an open atmosphere of discussion, where questions are asked, suggestions are made, and everyone feels that it’s easy to speak about their own doubts and insights. An open mindset towards quality improvement is a very useful thing to have in a kick-off. If multiple departments are starting to use Validation Manager, kick-offs are often arranged separately for each of them to keep the number of participants small and the discussion relevant for everyone.

For the kick-off meeting to run smoothly, every participant should clearly see what’s being shared and be able to join the discussion. A good way to do this is to have the meeting in a meeting room where content is being shared on a big screen. In a remote kick-off, another good option is that everyone has their own computers. Either way, access to the internet is required.

What happens during the kick-off meeting?

During the kick-off, we’ll go through a few topics, including:

• How you look at verifications and how you have done them in the past. The goal is to get a better idea about how to best get started with Validation Manager.

• What kind of verifications you have ongoing or will have in the near future, and how they are scheduled? That’s because we want to identify where you would benefit from using Validation Manager at the moment and within the near weeks.

• What’s the best way for you to transfer data into Validation Manager, and is there something that needs to be done to enable that? Together we will figure that out, no matter if the data comes from different instruments directly, LIS or middleware systems, or if it’s currently handled in Excel spreadsheets.

In a kick-off, we try to give you realistic expectations on what Validation Manager can do. We may talk about what kind of changes it may require from you to be able to get full benefits out of using the product. Often, we discuss the benefits of different verification protocols. This helps you make decisions on how to do your verifications in the future.

What do verifications have to do with quality?

In a kick-off, we will also talk about the quality mindset in laboratories. The reason for this is that some laboratories focus on the wrong things in their verifications.

For example, in reporting, they may have practices that are time consuming but give little relevant information about verifications. Many monitor correlation coefficient without understanding what you really can deduce from it, or use the ordinary linear regression model in cases where it’s not really suitable.

When starting with Validation Manager, some laboratories just expect to get a fancier version of Excel to run their verifications as they’ve always been run. It’s important to understand that Validation Manager is not Excel.

It’s a lot more: a chance to start doing verifications smarter, with less effort and more insight into your results.

But there may be some aspects that make you miss your old Excel sheets.

With Excel, there may be aspects that make you feel a little unsure about what you are doing. Starting to use Validation Manager often reveals these problems in existing processes. It can feel painful to come face to face with these things, realizing the flaws of how you’ve done something before.

The pain points and their severity vary from one laboratory to another. That’s why it’s good to get us all on the same page about these issues immediately during the kick-off. It helps us plan the trainings and offer the support you need.

After all, we have a common goal of improving laboratory quality and making your job easier.

The training phase

Soon after the kick-off, we will have a training session. What will be trained depends on what you will need in your first verifications. The main goal of the training is to teach you the basic workflow in Validation Manager through a couple of relevant examples. That way, you know what to do in your first verifications.

After the training, most users are able to learn more on their own. But, if you feel like you need further training to get more familiar with different features of Validation Manager, we are happy to offer this tailored to your needs.

Preparing for training

To ensure everyone gets the most out of the training, we limit the number of participants to 8-10 people per session. Everyone should have their own computers with access to internet. For the training to happen smoothly, it is helpful if everyone can access their e-mails from the computer they are using.

Sometimes there are big differences between participants; how easy it is for them to get familiar with new software. It may happen that some people get bored as they find the tasks are easy and quick to do. At the same time, others may get lost. It may help to have people do the exercises in pairs. In this way, both can work on their own computers and help each other if one gets stuck. This enhances the learning for both. Optionally, it is possible to have multiple trainings for different user groups.

Often, we end the training with helping you start your first real verification projects in Validation Manager. So, it’s good to consider in advance how you could use Validation Manager in your work at the moment.

What happens in a training session?

Often there are training participants who have never seen Validation Manager, or don’t remember much of what they have seen. That’s why we tend to start with a product introduction and a demo. As the demo describes the main workflow we will be rehearsing, it helps set your learning goals for the training. Most of the training is hands-on exercises that will help you get your own verifications done.

The content of the training depends on what you need right now. In a typical training, we conduct a verification project containing one study to find precision (and possibly TAE or some other accuracy parameter), and a comparison study to find bias. We then create the verification report to get you familiar with the whole process flow. We also introduce the administration features to make sure that you know everything necessary to conduct your verification studies.

Overall, we will proceed step by step. We’ll explain the goal of what we’ll be doing next, briefly introduce the relevant protocols and show you how to do things in Validation Manager. You will do the example verification by yourself using instructions at every step and can ask questions at any time.

The first projects

To enhance your learning, it would be good if you could start using Validation Manager as soon as you get your production credentials. And besides, the more use you find for Validation Manager, the easier your work becomes.

Often Validation Manager is purchased when a big verification is coming up. But, due to challenges in instrument installations or for other reasons, the schedule of the big verification is sometimes postponed.

If you wait for a month or two after the training before starting to use Validation Manager, it will be really difficult for you to get your verification running smoothly. And, even if there are no problems with the schedule, starting with the biggest and most complex project might be overwhelming.

That’s why we recommend using Validation Manager for smaller needs first. You then get to rehearse using Validation Manager so that everything will be clear when you finally get your hands on the big verification. And you will benefit from those small verifications too.

Beginning to use Validation Manager is a good place to start a habit of recurring parallel instrument comparisons. You can also use Validation Manager to measure lot-to-lot variation, validate your in-house tests, do cross-site comparisons and extraction method comparisons. What’s more, you can gather your control data into Validation Manager.

There’s a lot that you can do and doing these things in Validation Manager helps you standardize your verifications, save time, and become a fluent Validation Manager user.

When things go bumpy

Most of our users find Validation Manager quite intuitive to use. Yet, on their very first verifications, many of them encounter things that they find puzzling or don’t know what to do next.

When that happens, you should contact our customer support. Use the chat feature on Validation Manager or send us an e-mail describing what you were trying to do and where you got stuck.

There are no stupid questions. Our customer support genuinely wants to help you. In most cases, we have rather simple answers to help you continue your workflow.

We offer customer support in English and in Finnish. We can process questions in some other West European languages as well, but it may cause some delay. At the moment, all answers will be given in English or in Finnish. Sometimes we can also schedule a Teams meeting to help you with your tasks.

If you feel like you need intensive support to get your first verification done, you may get a little discouraged. But experience has shown that practically all of our users quickly learn to use the product in a way that saves them time compared with how they worked with verifications before. Many users ask multiple questions during the first few weeks, but that’s just part of their learning process. The more you use Validation Manager, the easier it is for you to find your way around, and the less need there is for our help.

Remember you can and should always contact our support when you have questions. In addition to helping you in the situation at hand, we use your questions and feedback when we plan our product development, user guide improvements and our blog content.

The check-up phase

After you’ve used Validation Manager for a couple of weeks, we’ll have a short check-up meeting to see how things are going. The purpose of this meeting is to reserve time to discuss your impressions and experiences in using Validation Manager. We’ll make sure everything is set up and works as discussed during the kick-off (both from ours and the customer’s side).

You get a chance to ask questions that have arisen, and we will answer them. Together we can find ways to fine-tune your processes to make things easier for you.

We will also:

• Discuss about your next upcoming verifications.

• See if there are needs related to instrument integrations or report templates.

• Seek to find clear steps to widen your use of Validation Manager and get it better integrated into your processes.

How to make it bigger?

Validation Manager can be used as a tool to ease your work with verifications. But it can be a lot more. It gives you:

• Better visibility of your results than any Excel-based solution can give.

• A possibility to standardize your processes and update your verification protocols to follow the latest guidelines.

• A reason to reshape your data management to get rid of manual work.

• Time to concentrate on things that are relevant and cannot be automatized.

• More information about your laboratory quality than you had thought possible.

If you want to, you can order additional trainings. You can use them to deepen your skills with Validation Manager. In addition to product trainings, we also have trainings to give you better understanding of the statistics behind the verification protocols.

And, if you have any ideas on how to make the product even better, we are always happy to hear about them. So far, we’ve built Validation Manager in close collaboration with our customers, making our product development decisions based on the needs of our users. That’s the way we intend to continue with our product portfolio. Your feedback makes it easier for us to serve you better.