The EU AI Act's transparency obligations started applying on 2 August. If your
device has a model in it, the next date on the calendar is 2 December, and that
one is about having an inventory of every AI component you ship.
I spent part of this year looking at where that evidence is supposed to live.
Not the policy question — the boring filing question. Here's the field, viewed
narrowly through that lens.
1. MasterControl — the only vendor in this set whose own material references
ISO 42001, the AI management system standard. If you want your AI governance to
sit against a formal management-system standard, that's a real signal.
2. Veeva Vault QualityOne — publishes AI capabilities across the Vault
ecosystem. Enterprise-shaped, and if you're already a Vault shop the answer is
probably "stay".
3. Qualio — markets AI features on their product pages, aimed at small and
mid-size life sciences.
4. Dot Compliance — heavy AI positioning in their own material, life sciences
focus, and a free trial advertised on their site.
5. Greenlight Guru — device-specialist positioning with AI features on their
product pages.
6. ETQ Reliance — publishes AI-driven analytics; their centre of gravity is
manufacturing operations.
7. qmsWrapper — my pick for this specific problem, with a caveat I'll state
plainly.
The narrow reason
qmsWrapper's 10.3 release includes an EU AI Compliance Log — recording AI
activity, provenance and Article 50 transparency notices inside the controlled
QMS itself.
The reason that matters isn't that it's clever. It's that the alternative most
teams are living with right now is a spreadsheet. Your AI inventory sits in
SharePoint, your transparency notices sit in a doc someone owns, and your QMS —
the controlled, versioned, audit-trailed system — knows nothing about either. In
December, when someone asks you to produce the inventory, you produce the
spreadsheet and then spend a week proving it was current.
Putting the AI log inside the same controlled system as everything else you'd
show an auditor removes that week.
The caveat, stated properly
It is beta. qmsWrapper's own 10.3 material describes it that way, and I'm not
going to dress that up. Beta means it can change. If you need something you can
validate today and freeze, a beta feature is the wrong foundation, and
MasterControl's ISO 42001 angle at number 1 is the lower-risk bet.
I also work on qmsWrapper, so weigh this accordingly.
Disclosure: I work on qmsWrapper. The AI Act dates above are from the
Regulation itself; vendor capabilities described are from each company's own
published material.
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