A few things:

– Cost to pay someone to do some of the work thats automated in an eQMS

– Audit findings that could be better addressed through an electronic QMS

For those who’ve moved from a manual QMS to an eQMS:

What was the tipping point?

Audit readiness? Team growth? Regulatory pressure?

Sharing a visual comparison we made that looks at the main differences between the two. We would love to hear what pushed your team to modernize this system (or why you haven’t yet).

Thanks for the reply Aaron. That’s good to know about Ketryx being actually a time saver at SaMD startup. Yeah it seems all tools are adding in some AI features of some kind. I’ll start playing around with Ketryx, thanks!

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…

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Cullom, I’ve been using Ketryx for the past 6 months with a SaMD startup. Ketryx is architected differently from other SW tools I’ve used since it’s intended to work as a layer over other tools such as Jira. So it might not be a good fit for everyone but it’s working well for this startup. Ketryx is designed for fast-moving SW teams and…

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Wondering if anyone has tried or worked in Ketryx or any other eQMS platform with promises of agentic AI drastically reducing time? I assume it’s at least a bit oversold still at this point, but just curious if these tools could start reducing time/aid in overall efficacy without adding issues.

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…

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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…

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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…

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

FYI: I recently came across this handy comparison table for various eQMS software packages by OpenRegulatory: https://openregulatory.com/qms_software

They also have some more in-depth descriptions for particular eQMS packages on their website. I’m curious for anyone who has direct experience implementing and/or using one of these eQMS if…

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