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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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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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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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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Joe,

Expanding on what Niki wrote, this is an important topic that seems to lead to a lot of confusion and flawed methodology. The P1, P2 probabilities are part of the ISO 14971 risk model but that doesn’t mean they should be explicit columns in a risk table. My recommendation is to make sure that everyone involved in risk assessments…

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