[Holly]

Thanks this is wonderful! I would be interested to see how @quickvault-by-veeva compares?

[Aaron]

Holly, I don’t personally have any experience with Veeva software tools but I think this forum would be a great place to collect that kind of information (somebody out there must know).

For anyone trying to make an informed, rational decision about purchasing an eQMS system, it’s very hard to get clear information. Insights from everyone’s personal experiences would be a way to cut through that ‘fog’ about the differences between various software options.

[QuickVault]

Hi Aaron!

Thanks for sharing this overview, I had not come across this list before.

First off – I have first-hand experience with using a few of these in my career. In general, the eQMS that you should chose should be based on a) your current needs, and b) needs that you foresee in the future as you grow your business.

As for the list of products and the comparisons, a few things to bare in mind: OpenRegulatory is the one who made it, and all the solutions in the list are their competitors in one shape or form. That will naturally skew the information as well as the ranking. Additionally, it is a major spread in the types of software solutions listed, it is not really an apples to apples comparison. Some solutions are not even an eQMS (JIra, Google Drive), others are limited in eQMS functionality (Dot Compliance), others are broader solutions but life science industry agnostic (Qualio sells to pharma, biotech, MedTech etc.). Some solutions are MedTech specific, such as Greenlight Guru, that has functionality to manage design and development / Design Controls etc. Lastly, the categories/columns of what the solutions are compared against each other is very random and not that useful. It would have been better to create a table for say MedTech specific eQMS solutions, and list the various functional areas such as doc control, training, quality events, design control, risk management, supplier management, submissions etc.

The solution we provide, QuickVault by Veeva (which is not in the list), is a MedTech specific eQSM platform that provides cross-functional value and efficiency for MedTech companies. It helps our customers bring their devices to the market, but it also also serves as a platform for commercial growth and success. More information here: https://quickvault.veeva.com/

The last thing to mention that is also very important when it comes to eQMS selection is around who the company is that provides the product. Many eQMS providers are startups that are struggling, an dmay not be in business in a few years. There’s a lot of consolidation in the eQMS market, as an example, Greenlight Guru bought both Enzyme and UltraLight this year, and those customers are now forced into a change to Greenlight or into multi-year contracts. I am mentioning this bcs the selection of an eQMS is a strategic decision, and you are partnering with the provider for a long time – you really want to do the implementation once, and not have to replace the solution at a later date . On our website in the resource center, we have a few educational pieces around eQMS selection, such as this blog post: https://quickvault.veeva.com/resources/comprehensive-guide-medtech-eqms-selection/

Hopefully this helps clarify! I would be happy to hop on a short call and discuss/explain further.

Best,

Axel Strombergsson, VP, QuickVault

quickvault.veeva.com

Device-To-Market Solution For MedTech - QuickVault by Veeva

QuickVault is the only all-in-one solution that unifies design, regulatory, quality management, & operations in one platform built for MedTech. Book your demo!

[Aaron]

Alex,

Thank you for the detailed reply. Those are very good points that you bring up and I agree that companies don’t always think carefully enough about their real needs from an eQMS or other enterprise software. In my consulting work I focus on risk management and design controls and don’t set up quality systems. However, I work with many startups and am often asked for a recommendation for an eQMS, especially for ones that are suitable to small companies on a tight budget.

More frequently, I help clients implement requirements management tools, test management tools, and issue tracking tools which used to be referred to as “ALM systems” but now I find they’re sometimes called eQMS, which is confusing. As you point out, a good comparison table should show how very different some of these software packages are. For example, Jira is an issue tracking tool that over the past 15 years has acquired many more features but it’s still best suited for tracking tasks and issues in tickets. It would be a stretch to call it an eQMS but I believe it was included in the comparison table because SW teams who are new to medical devices may think they can do everything with Jira (or GitHub or G-suite).

So I think a new version of the comparison table I shared, that actually compares key eQMS features of various SW tools (not just pricing, licensing, hosting) would be very valuable in this forum.

Any volunteers?

-Aaron

[Aaron]

UPDATE: I’ve met a couple of times recently with Alex Strombergsson from Veeva to discuss the QuickVault eQMS and was pleased with what I saw. This is not the same as the Vault eQMS. QuickVault is a new streamlined, pre-configured version which is designed for small to medium-sized medical device companies, who need something that can be up and running quickly. Veeva offers a flexible licensing structure for QuickVault for companies on a tight budget. I recommend that anyone shopping for an eQMS include QuickVault on their short list.