In medical device manufacturing, ensuring product quality, safety, and regulatory compliance are of paramount importance, but they also cause paramount pain. The setup of your Quality Management System (QMS) is a make or break factor for your sanity.

Maintaining a QMS in your company forces you to define processes for everything, to create a lot of documentation and to introduce gateways that slow down your software development. In short: it is pain.

Our lizard brain is wired to avoid pain, so it is logical that medical device manufacturers are looking for solutions to automate their pain away. The main expectations are

• we want to “automate regulatory”
• we set it up once and then it maintains itself
• we don’t need a full-time employee to deal with this.

While it is true that certain aspects of the work can be automated and there are many consultants and softwares out there that promise exactly that, it is worthwhile to take a closer look at what can actually expected.

If we want to talk about automation, we need to define the term. Depending on where you come from, this might mean something different for you:

As a corporate dinosaur, automation might mean for you switching from a paper-based QMS to a digital one with digital signatures (whoo hoo). Many large eQMS software providers advertise their “automation” of the QMS, but what they actually mean is that it is digital. I admit, this is huge. But only if you compare it to the status from 20 years ago. As a digital native, that wouldn’t get me out of bed in the mornings.

If you’re a digital entrepreneur, you have never experienced paper-based QMS work and automation for you probably means creating the actual content (documents) automatically. You might expect that the regulatory software could just be connected to your Jira project and then it magically throws compliant documents at you. Never to worry about ever again. I think that would be everyone’s dream, but this is not realistic. The regulations are heavily dependent on someone taking on the responsibility for the regulatory compliance in a company.

Let’s make a reality check.

Which degree of automation is possible right now?

1. Automated Document Control

If you use a powerful cloud-based document control system, you don’t have to worry about the following things anymore:

• real-time access to the latest versions of documents
• archival and retention periods
• access management for authorized personnel
• collaboration when creating or editing the documents

However, you still have to:

• come up with the content yourself
• ensure compliance with all applicable regulations
• cross-link with other documents manually

2. Risk Management and Compliance Tracking

This is the place where the first disillusion happens. Risk Management is so individual and so complex that there’s no one-fits-all solution to it that would take this pain away from you. Likewise, compliance tracking is hard to automate because (thank God) there’s a lot of room for interpretation in the guidances and regulations so that you’re flexible. Depending on your use case different requirements apply, so checking compliance remains a manual act.

However, already now you could potentially reduce your workload like this:

• Linking risk controls to software requirements (automatic traceability)
• Linking customer feedback to risk management input (trend analysis)
• Real-time risk tracking and crazy data analysis (with tools) – this might actually increase your workload rather than reduce it
• Linking compliance checklists to implementing documents

That’s not much.

You still have to:

• Anticipate and observe the risks yourself
• Estimate severity and probability (at least for the first release)
• Come up with risk control measures
• Evaluate the benefit-risk ratio
• Check updates to regulatory requirements and their applicability to you

The TechDoc tool of our eQMS software Formwork contains a powerful Risk Management functionality that makes managing your medical device risks easy and compliant. It even creates the traceability to your design input and it automatically evaluates whether a risk is acceptable or not based on your Risk Matrix. Feel free to request trial access.

3. Supplier Management and Audits

Sorry, no automation here. It would be great if audits would be automated (major pain factor). For that, the Notified Bodies would need to ramp up their AI capabilities in that regard. Having known the industry for a couple of years now, I have no hope that this will ever happen.

There are most likely tools out there for supplier selection and supplier surveillance, but unless you have thousands of suppliers and you’re conducting regular supplier audits, those tools won’t make your life easier.

Better stick to the good old checklists and tables. You still have to check the supplied goods (manually) and note down how satisfied you are with the service anyway.

4. Training and Competency Management

To ensure the workforce is adequately trained and competent, automation can be employed to manage employee training programs.

Everything is possible here:

• Monitor employee training progress
• Assigning trainings to employees (role-based)
• Scheduling refresher trainings
• Notify employees about re-training needs when a process has changed

What you still need to do yourself:

• Verification of the training (e.g. creating a quiz and keeping it up-to-date)
• Define the roles and which trainings they need

In our eQMS tool Formwork, the Training functionality lets you create employee trainings with quiz questions. You can then assign the trainings to everyone in your company for self-study and you can tick off the task from your list.

5. Corrective and Preventive Action (CAPA) Management

Meh, you cannot automate much here:

• Automatically track deadlines of defined actions
• Ping people
• Create traceability between CAPAs and their remediations

The main work is still manual though:

• Creating the CAPA ticket
• Root Cause Analysis
• Defining Actions
• Checking the Effectiveness of the actions

Like with the training functionality, our eQMS tool Formwork provides a structured interface for managing your CAPAs. The underlying form contains all the required input fields and the tool maintains a list where you can see which CAPAs are still open and which are closed already. Try it out!

6. Performance Monitoring and Continuous Improvement

The QMS requires you to define key performance indicators (KPIs) for every process. With those metrics you will monitor whether your process is working properly and where you could improve them.

Tracking KPIs for processes could be facilitated with a tool, but then again, you still need to supply the input yourself manually. You could also just use a table for that. In the end, you’ll have to do the evaluation yourself anyway. No tool will understand what the process actually does and whether an improvement makes actually sense or not.

If you’re working for a large corporate where you’re easily losing the overview of your processes, it might make sense to have a tool tracking your KPIs, but for startups, I wouldn’t recommend that.

Conclusion

While digital tools help a lot in streamlining the QMS and making it more interactive/collaborative, the content still has to be created. A human brain is often needed to draw the correct conclusions. The cases are so specific, that generative AI would probably not help a lot here. Hopefully, the development towards automation also picks up on the regulators side. Otherwise, we’ll have to continue managing the regulator’s paper-based world with our digital tools as good as possible. I hope this article helped you in understanding what can be expected of eQMS softwares and the degree of automation that can be achieved regarding medical device compliance. Despite us being the developers of it (or exactly because of this), I believe that the best tool out there for managing the QMS at the moment is Formwork.