Choosing and installing a med tech eQMS is a resource and time-hungry undertaking. And the stakes are high. If you get it wrong you could be saddled with a system that slows you down and frustrates your team with excessive bureaucracy. Get it right and you can design and deliver innovation more efficiently, building compliance capabilities seamlessly into the ‘way you do things’. So, what do you need to know before you commit to a solution?
Some eQMS products on the market right now are complicated and heavy duty life science solutions favoured by large, global organisations. These typically take many months to implement by IT specialists and are a challenge to maintain without a dedicated quality management team on hand.
There are other more scalable, cloud-based options on the market, too. These include dedicated med-dev options (like the ever popular Greenlight Guru) marketed to SMEs as turnkey options to rapidly achieve a compliant product development process. Others might choose non-specialist eQMS products and try to marshal them to achieve the compliance requirements specified by the FDA and other regulators.
But whatever route you choose to go, as an SME we think there are some key considerations that should be driving your decision making around an eQMS.
1.How much flexibility will you need?
You may feel reassured by the ‘heavy weight’ credentials of some med tech eQMS or feel that preconfigured compliance solutions, SOP templates and workflows will bring the right sense of discipline to your development process. You may also feel that by following these ways of working you will have a defined path to develop a compliant product that will get you to market more quickly. But what might seem at first like the robust approach you need to martial your ideas could end up becoming a strait-jacket. We would argue that you need to be able to find a solution that gives you the freedom to adopt and adapt the ways of working and SOPS that are best for you, rather than restrict the way you approach your dev process.
2. What specific regulatory requirements do you need to meet?
That said, you should be sure that the system has the ability and track record of meeting the relevant regulatory requirements and industry standards. For example, how easy will it be to set up the design controls required by ISO 13485 using their software? How do the available tools meet the specific e-signature requirements outlined in 21 CFR part 11 or the MHRA GxP Guidelines? Is the authentication process robust enough to prove intent and identity of signatories in your system? Are the signature manifestations in your quality documentation sufficient to match the regulation?
3. How will validation be supported?
Both the FDA and the MHRA require you to validate the eQMS software that you are using. You need to be sure that you’ll get the support you need to undertake this process. A typical software validation pack provided by a vendor should include:
- Validation Report
- IQ template
- A PQ template,
- Completed PQ-OP example
- Test specifications and results.
4. How will an eQMS right-size to your needs?
In our experience, the ability to ‘right size’ often makes the difference between supporting a process flexible enough to let you work more freely and efficiently in the early stages and being restricted from the start by an overly bureaucratic system.
At the beginning of your project, your eQMS should operate as a basic digital framework for your development process - a repository for the regulatory and documentation that you are gradually assembling. It should also function as a collaborative hub for the generation of ideas. However, as you grow and begin to move beyond ideation it should be able to support more sophisticated project management and compliance capabilities (phase gating, design control, publication of your Design History File etc). The solution should scale with you, not expect you to work within their prescribed limits.
5. Do you need a supplier who only deals in med tech?
If you’re looking for an eQMS for your med tech company you’ll want to choose a supplier who has experience in the industry. That’s a given. A lot of the stuff you’ll need the system to do is highly specific. But this doesn’t have to be an exclusive focus. Choosing a supplier who works in other sectors, too, and has developed tools to assist them in their specific challenges, may add unexpected value along the way. Agile collaboration tools created for high tech new product developers, may give you the flexibility you need early on in your project that an old school Pharma or MedDev eQMS just wouldn’t contain.
6. How much will it cost?
In the worst case scenarios an eQMS solution can tie you up in red tape while costing you tens of thousands a year for the privilege. It’s worth understanding the full extent of charges you could incur and what you’ll get in return. Most providers will charge you an initial fee and an annual license fee for a certain number of seats. This may seem reasonable until you begin to add in the hidden extras. Will your annual fee be based on the capitalisation of your company? If so and you’re still in the development stage of your project, you could be charged at the top rate even though you’re unlikely to be making money from your product for a number of years. Will they charge you extra for certain ‘compulsary’ modules? Will they charge you to import and migrate data into the system? Will they charge you for training or account management? Will the system require installation by a consultant for whom you will have to pay extra?
These are just a few of the considerations that should be driving med tech developers as they’re considering options for an eQMS. There are many solutions out there that are costly and unnecessarily inflexible. There are some digital controls that you will definitely require to produce a compliant product, but you may not wish for your work flows and SOPs to be completely prescribed by your solution supplier.