With new software driving incredible innovation in medical technology, industry regulations are zooming in on the management of tools more than ever before. Validating tools for the development of safety-critical products can seem like an overwhelming process if you haven’t done it before. The more complex the tool in question is, the more complex the validation process becomes. That being said, there are many benefits that come along with making the effort to validate your software tools, and not just for meeting regulatory requirements. Read on to find out more about tool validation, how it can help your business, and best practices to help you get started.
Why is tool validation necessary in medical device development?
Tool qualification in MedTech development is the process of evaluating, documenting, and demonstrating whether a tool that you are using to create a product (like a medical device for example) is up to standard. Nowadays, companies use a huge range of applications to carry out their work, like email clients, project management suites, quality management systems, communications platforms, and much, much more. All of these are involved in some way or another, but not all of them need to be validated.
MedTech businesses in particular often leverage the latest innovations that technology has to offer in order to create cutting-edge products and therapies. While these tools are not part of the medical devices or products themselves, they do support the end-product at some point (or even throughout) its lifecycle. If the tool in question can have an impact on the quality and safety of the device, then it probably needs to be validated in order to meet regulatory requirements, reassure clients and end-users, and enable the business to scale. Before we go further, let’s take a closer look at the benefits tool validation provides.
How to Validate Your ALM Tool in Medical Device Development?
Benefits of tool qualification processes
In addition to being a direct regulatory requirement in some markets, validating tools bring significant benefits to your organization, as well as the opportunity to improve and grow your organization as a whole. Here are some of the main ones:
- It’s a good selling point: being able to confidently say that your tools are validated will reassure customers and end-users that they’re getting the highest quality product possible. It’ll also help you win new business and give you an edge over competitors who aren’t validating their tools.
- It gets your team on the same page: the process of validating tools often involves many company stakeholders. This can be a great opportunity to familiarize colleagues from different departments with the important tools you use, get their buy-in, and even get them in the tools themselves for more fluid collaboration.
- It helps your business scale: the ability to win more clients, increase productivity and complete audits smoothly and quickly will help your business flourish instead of getting stuck in costly delays.
- It makes you compliant: last but not least, validating your tools means you are compliant with industry and regional regulations, and you can avoid any unpleasant delays or fines as a result of not using validated tools.
Challenges of tool validation
Despite the benefits that come with validating tools, organizations are often wary of the process due to the complexity and resources required, and sometimes due to a lack of stakeholder buy-in. However, non-compliance can result in fines from regulatory authorities like the FDA (Food and Drug Administration in the U.S.) and EMA (the European Medicines Agency), as well as not being able to bring devices, services, and therapies to market.
This is because healthcare and medical technology — life sciences as a whole, really — are extremely regulated industries. Apart from general audits, many companies are also subject to supplier audits in which they need to demonstrate that the tools they use to create products for their customers will work as intended and are compliant to boot.
Regulations are meticulous, extensive, and updated regularly. In order to be able to stay on top of these industry requirements and comply with them, it’s vital to validate your tools as soon as possible — and conduct regular reviews and updates.
Validating Software Tools in Safety-Critical Development
Best practices for MedTech tool validation
Now that we’ve explored the importance of tool validation and the benefits it can bring to your organization, it’s the perfect time to examine some best practices to help you get started. Here are our top 7 tips for validating tools in MedTech development and safety-critical industries as a whole.
- If possible, start before you acquire the tool
Of course, you can still do a retrospective validation of a tool that you’re already using. That being said, it is easier to validate the tool before it’s in place in your business, rather than after. Knowing what you want, planning it, and setting up the system configuration just right all makes it a smoother process.
- Use an industry guideline
Industry guidelines with widely accepted standards have been developed in order to make this complex process a little bit easier (or at the very least, clearer). In the life sciences industry, a commonly used guideline includes the Good Automated Manufacturing Practice guidelines (GAMP® 5). This framework for validation covers all aspects of the product lifecycle from planning to system retirement, and outlines how you should do things, name items, and set up roles and responsibilities, amongst other handy tips. This helps understand how a validation process, in general, is carried out. In the case of development tools, you’ll want to consider the intended use of the platform, e.g. each of the features you’ll be using, and validate the tool based on those use cases.
- Put the right person in charge
Do not underestimate the process of validating tools in safety-critical industries. The tools themselves are often really complex, with tons of functionalities that your team might not be exhaustively familiar with. Validation is often a bigger task than expected and takes a chunk of time to carry out. Hire a software validation professional to do it, or assign a team member with relevant experience to project manage it, and make sure to allocate sufficient time and resources to ensure it’s a success. Alternatively, if your tool vendor offers such a service, consider having your tool validated by the vendor for a fraction of the time and costs of carrying out a manual validation process.
- Involve stakeholders from the beginning
Throughout the process of validating tools, you’ll find that you end up needing inputs, approvals, and sign-offs from a variety of individuals in your organization, spanning different teams and departments. It’s best to set the validation process up as a project from the beginning and involve them from the start, rather than dragging people in one by one as you go along in a haphazard manner.
- Use the vendors as a source
If you can, work with the service providers or product creators themselves and ask them to look over your validation documentation before it’s executed. They are the experts for their own tools and can help you understand what your processes and configuration should look like, as well as fully grasp the functionalities of the tool.
- Document everything
The basic idea is that if you didn’t write it down (or get screenshots), it didn’t happen. A hugely important part of validation is that you have evidence and documentation to show that you have documented how you’re planning to use the tool; have identified all affected functionality and that a testing protocol was run to assess the correct functioning of those features. This shows customers and auditors that everything is good to go and you have the proof to back it up.
- Future-proof your setup
Once you’ve validated your tools, you need to maintain that validated state. Tools are often updated and upgraded throughout their lifecycle, and these changes can affect their status. Place every tool under change control processes and make sure to conduct periodic reviews to ensure you can still consider them to be validated.
With regulatory scrutiny increasing across safety-critical industries, MedTech tool validation is more important than ever when it comes to optimizing your software development and compliance efforts. You need to be able to document and demonstrate that the digital tools you use to meet regulatory and quality requirements, but where to start? Check out our webinar for more detailed guidance on tool validation in modern medicine here:
Best Practices for Tool Validation: A Use Case in Modern Medicine by TrakCel