Choosing the best quality management system (QMS) software for your company is a major decision. However, trying to figure out which solution is the right one can be an overwhelming task. When researching your options, it’s important to ask the right questions to help ensure you make the right choice.
At Enzyme, we want to help you find the best QMS solution for your company—even if it’s not us. That’s why we’ve created this list of questions to ask QMS vendors to help you make your decision.
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- Is your QMS software validated? If so, do you provide validation documentation? If not, how much does validation cost?
QMS solutions that are validated out-of-box (like Enzyme) will save you time and money. Just confirm the vendor can provide the validation documentation you need to stay compliant. If the QMS software isn’t validated, find out how much it’s going to cost and how long it’s going to take. These are both potential deal-breakers depending on your budget and timeline.
_ - Is your system proprietary or are you built on a third-party platform that depends on another company?
If the QMS solution is built on the company’s own platform, they have full control of the system, which means they can address any potential issues directly. However, if the QMS solution is built on a third-party platform, then the QMS vendor is at the mercy of that third-party company whenever any issues arise.
_ - Do all user changes to controlled documents and records require a 21 CFR Part 11 compliant e-signature?
Whether you need Part 11 compliance now or later, it’s best to pick a QMS solution that offers it from the start so that you don’t have to migrate to another system later. But beware—some QMS vendors will tell you that they’re Part 11 compliant when they aren’t. How can you tell? One way is to see if e-signatures are required to approve or change documents and records. If they’re not, then the QMS software isn’t Part 11 compliant, no matter what the vendor says.
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- How are documents organized in your QMS software?
Being able to find and retrieve documents quickly and easily is critical, especially in high-pressure situations like audits or when putting together a regulatory submission. Since everyone likes to organize their documents differently, make sure your QMS software is flexible enough to accommodate your team’s way of working, whether that’s using tags, a foldering system, or both (like Enzyme). This is important for setting up user permissions/access as well.
_ - How do I export my data out of your QMS software? How difficult or easy is it to do this?
The data being stored in your QMS platform is one of your most precious commodities. Make sure that what goes in can come back out so you’re not being held hostage by your QMS provider. If it’s difficult to export your data back out of the system, not only will it be challenging to analyze and leverage your data, but if you ever decide to switch to a different QMS solution, the migration will be a nightmare.
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_ - What kind of integrations do you provide?
The number of integrations a QMS provider offers tells you a lot about how flexible the system is. The more integrations there are, the more you’ll be able to keep using the tools you and your team already love. If the QMS software doesn’t integrate with your existing tools, you and your team are going to have to adapt the way you work to your QMS software instead of the other way around. Learning new tools and workflows on top of a new QMS solution is a burden a lot of teams would prefer to avoid.
_ - How configurable is your QMS software?
Every company and industry differ in what they need from their QMS software. It’s important to find out whether the vendor’s QMS solution can be configured to meet your needs. Otherwise, you might be trying to fit a square peg in a round hole. The best option is to find a QMS solution that is validated out-of-the-box to save you time and money, but also configurable enough that it can adapt to your workflows and requirements.
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- How long does onboarding take? How much support do you provide?
A major barrier to successfully implementing QMS software is often how long onboarding takes and how complicated the process is. Many companies purchase a QMS solution and then fail to get it off the ground due to one or both of these reasons. Make sure you understand the vendor’s onboarding timeline and also how much support the company is going to provide along the way. If you think you’ll need more help than what the company includes with your package, find out what additional options are available and factor that cost and time into your decision.
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- What industries do you specialize in serving?
There are significant differences across the life science industries when it comes to processes, needs, and requirements. Make sure the QMS solution you pick was designed with your particular industry in mind so you know it’s a good fit. Otherwise, that particular QMS software might be missing critical workflows and functions that you need for your business and/or you may be paying for modules and functions you don’t need.
_ - What type of consulting services do you offer? Can your team write regulatory submissions and/or serve as representatives to notified bodies?
If you’re going to invest time, money, and effort into a QMS vendor, it’s important to know what other services they offer. That way, if you ever need additional help, you know what they can and can’t do. Whether it’s optimizing your QMS, consulting on regulatory strategy, or making sure you’re audit-ready, it can be beneficial to do that with a vendor you already trust and who already knows your QMS.
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Now that you know which questions to ask, head on over to our quiz, “What’s the Best QMS for My Company?” to get three personalized recommendations on which QMS vendors you should look into.
