Hey everyone,
I’m building Qlauson, an AI system designed for industries where recurring issues are expensive, regulated, and dangerous — especially:
MedTech
Pharma
Manufacturing
Food production
Industrial operations
We just opened early sign-ups for free early access.
In most operational environments, when something goes wrong:
a defect appears
an incident is logged
a deviation is recorded
an audit question comes up
The first question is always:
“Has this happened before?”
Right now, answering that takes hours or days across:
Jira / ticketing systems
CAPA systems
SharePoint / Confluence
emails
local files
and usually… asking someone who “remembers”
What we keep seeing in regulated environments:
recurring incidents are not recognized early
CAPAs are recreated instead of reused
audit trails are fragmented
root cause analysis repeats from scratch
knowledge is trapped in different systems
This leads to:
repeated failures
wasted investigations
compliance risk
and preventable production issues
Qlauson is an AI-powered operational memory layer that connects:
incidents
quality events
CAPAs
audits
documentation
And answers:
“Has this happened before — anywhere in your systems?”
It then shows:
similar past cases
root causes
what CAPA was used
whether it actually worked
and what should be done now
We’re currently inviting early design partners from:
MedTech companies
pharmaceutical manufacturing
food production facilities
industrial manufacturing teams
quality / compliance / operations teams
Early access is:
free
feedback-driven
and directly influences product direction
We’re not just looking for users.
We’re looking for:
real operational pain
real incident history complexity
teams dealing with CAPA / audits / deviations
honest feedback on what actually helps vs what doesn’t
Early users will get:
free access during beta
priority feature requests
direct input into roadmap
custom integrations for your workflow if needed
Drop a comment or message me with:
your industry
what systems you currently use (Jira, QMS, SAP, etc.)
and what pain you have with recurring issues or investigations
I’ll personally onboard a small number of teams first.
If your work involves regulated environments, audits, or production quality systems — this is exactly the type of feedback we’re building around.
Problem space is real — CAPA duplication, knowledge fragmentation, audit trail reconstruction are multi-million dollar problems in regulated industries.
Three things to pressure-test:
Regulatory compliance is the gate, not the marketing. Quality leaders can't deploy AI touching CAPAs without 21 CFR Part 11, EU Annex 11, GxP validation, ALCOA+ data integrity. Without these, conversation ends at "how do I validate it?" Must address Part 11 path explicitly.
AI hallucination tolerance is zero in regulated context. Hallucinated citation = audit failure + regulatory action. Need strict provenance, auditable decision trails, conservative defaults, human-in-the-loop. Positioning should lead with trust mechanisms more than AI capabilities.
Wrong channel for design partner recruitment. IH audience is consumer founders. Quality VPs are on LinkedIn, in RAPS communities, at industry conferences (RAPS, ISPE, Pittcon, IFT FIRST). LinkedIn outbound to Quality VPs at mid-market companies works better than tier-1. Auditor recommendations open enterprise doors.
Existing competitors: MasterControl, Veeva QualityOne, Sparta TrackWise, ETQ Reliance, Greenlight Guru. Wedge isn't "QMS" — it's "AI cross-system memory layer connecting existing QMS to other knowledge sources." Beats "another QMS."
Enterprise sales cycles 6-18 months, annual contracts $50-500K. Model runway explicitly.
Thanks for the advise, however, our approach was not creating a RCA or CAPA tool.