traqx doesn't replace your systems — it makes them intelligent.
Layer 2 GxP Compliance Intelligence, built on top of Veeva, MasterControl, SAP & SharePoint. No migration. No template redesign. Your team stays in control of every signature.
Validation isn't broken. The friction around it is. Three moments your week probably already contains — and the version of the same week with traqx in it.
"It's the fifth review round on the same URS — and QA, the Validation Manager and Process Owner are still arguing whose interpretation of GAMP 5 is right."
The argument ends in round one, not round five. Every claim ships with a citation to SOP, regulation paragraph, and Industry Knowledge Base. Discussions are about facts, not opinions.
"You open the new system's URS template. It's blank. The first 120 pages will take three days, and you already know two sections will need rewriting after the next steering."
A grounded draft is waiting. Risk-classified, traceability-tagged, written against your SOPs. Review, instead of write — the URS is done by lunch.
"50 systems, 5 weeks, every December. The 'living' Traceability Matrix is reassembled by hand, the way it has been for 15 years."
The Matrix is always live, never assembled at year-end. Periodic Review goes from a 5-day project to a 2-hour review. The December marathon is over.
In every GxP project for the last 30 years, you had to choose two: faster, cheaper, or better. With traqx, you don't trade — you move all three at once. This is the central business case for AI in compliance.
| ⏱ Time | Faster has historically meant lower quality or higher budget. | URS in 30 minutes instead of 2–3 days — at the same or higher quality. |
| € Budget | Lower budget has historically meant less time or lower quality. | Lower cost via AI-assisted drafting. Fewer external consultants, fewer review rounds. |
| ✓ Quality | Higher quality has historically meant more time or more money. | Author-independent quality through the Industry Knowledge Base. The Junior delivers what the Senior delivers. |
For the first time in the history of GxP compliance, technology lets all three improve at once — without trading anything against anything else.
When "new system" makes you flinch — for good reason — read on. traqx removes the five buy-barriers that usually kill enterprise compliance-tooling projects. Not one, not three. All five.
Three steps. One signature. The AI proposes; the human disposes. Every claim is cited. Every action is logged in a 21 CFR Part 11–compliant audit trail. This is the only regulatorily defensible model for AI in GxP.
AI-assisted drafting on top of your templates and SOPs. Every section starts with an evidence-grounded proposal — not a blank page.
Your experts review, correct, approve. Every AI claim ships with a citation — discussions land on facts, not opinions.
Quality is measured continuously, not point-in-time. The audit trail is built as you work — not assembled at year-end.
A 120-page URS that used to take 2–3 days takes 30 minutes. Your Validation Manager reviews and approves — instead of starting from a blank document on Monday morning.
The cockpit on the right is the live product. The AI drafts in cyan. Evidence is pinned in monospace. The lime "approved" stamp lands when — and only when — a human signs. No autonomy. No black box. Your signature, your accountability, your audit trail.
Documentation is the start. Where the real leverage lives is across projects, SOPs, change control and global programmes — the lifecycle nobody else owns end-to-end. Four big use cases on the same engine. Buy CSV; the lifecycle expands without re-buying the platform.
From AI document generator to Single Source of Truth for the entire validation lifecycle. KPIs that emerge from real content events — never manually pasted into a status sheet again.
From 700 SOPs to the 47 that matter — in seconds. Then edit them with AI in side-by-side diff view. Mandatory SOP-impact gate in every Change Request — audit-defensible by default.
Your URS doesn't freeze at Go-Live. It lives — under controlled, audit-defensible change for 5–15 years. Every CR auto-scopes from a free-text description and pre-selects regression tests by risk.
One Template. N Factories. Bidirectional propagation — a Template change is instantly assessed against every active local rollout. Local deltas, central audit trail, no manual sync.
Why this matters · the Layer-2 thesis Konzern tools track workflow in silos: Jira for tasks, ServiceNow for changes, SharePoint for SOPs, Veeva for documents. None of them understand the content. traqx is the layer above — the one that reads the URS, knows which SOP is impacted, and tells you which 12 regression tests to run. That's why the same engine runs all four use cases. That's why one calendar entry propagates to ten projects. That's the leverage.
Quality, Digital, Validation, Project — the highest-leverage promise per role.
"Stay in control of a heterogeneous landscape. One standard across 12 sites. No personal liability."
"Deliver a visible AI win. Make QA a partner, not a blocker. Be the leader who landed AI in compliance."
"Methodologically excellent work that survives the toughest auditor — and finally, faster."
"Hit go-lives. Stop being held hostage by consultant availability. Make the next factory ship faster than the last."
Every GxP qualification or validation domain follows the same 5-stage pattern: SOP defines process · risk classification · templates define structure · execution within boundaries · traceability. traqx delivers the mechanic — the modules deliver the regulation. Buy one; the rest expands without re-buying the platform.
URS, FS, Risk, Test Plan, IQ/OQ/PQ, Traceability Matrix, VSR — generated, verified, audit-proof.
~85% overlap with CSV — the natural next step. URS through PQ, with risk-based right-sizing.
Design qualification through requalification — same engine, applied to particulate, microbial & HVAC.
Stage 1–3 process validation, with critical-process-parameter tracking and continued process verification.
Land & expand · why one platform The mechanic is identical across CSV, EQ, CRQ and PV — what changes is the regulation, the risk class, the templates. Start with CSV; the company-specific Knowledge Base you build only gets more valuable with every additional module.
Specialised categories die when they're confused with adjacent ones. Here's where traqx draws the line — explicitly. We respect what you've built. We do not respect the four ideas below being sold to you under our category name.
Generic LLMs cannot model the data structures, processes and templates of GxP industry. They don't know your SOPs, your internal quality standards, or the regulatory subtleties. A ChatGPT-drafted validation document would not survive an FDA inspection.
ships an Industry Knowledge Base with 17 years of GxP expertise across 80+ validated systems, customer-specific templates, and regulatory know-how. Generic models hallucinate; traqx cites.
Tools that put an API skin on an LLM deliver no compliance: no AI audit trail, no 21 CFR Part 11 conformity, no traceability, no source citation. In a regulated environment that's not insufficient — it's a risk.
is compliance-native — AI audit trail, Human-in-the-Loop, citation traceability, all built in from day one for regulated industries.
There are vendors with a similar pitch — but as closed systems that want to replace your DMS, QMS or ERP. That means new migration, new budget, new change management, new risks.
is the Layer 2 answer — built on top of existing systems, templates and processes. No system swap. No migration. Minimum entry barrier.
We were the consultants for 15 years — the ones companies were dependent on. We built traqx because we got tired of being the bottleneck.
is built so your team can do this themselves. System-Guided Validation + Industry Knowledge Base mean the expertise lives in the platform, not in the consultant's calendar.
traqx is not a generic AI startup that decided pharma looked profitable. We spent 15 years inside the validation projects of Boehringer Ingelheim and Johnson & Johnson — writing the documents, sitting through the audits, being the bottleneck. We built traqx because we knew, document by document, where the time leaks out.
traqx is built by a team that has run real CSV projects at scale — not by a team that read the GAMP 5 PDF last weekend. The Knowledge Base ships with every regulatory pattern we ever resolved.
Daniel Herrmann
17 years of pure GxP-compliance work. Personally validated 80+ systems at companies including Boehringer Ingelheim and J&J. Authored hundreds of URS, FS, and validation summary reports.
Alexander Schrot
50+ systems successfully programmed across regulated and non-regulated domains. Built the Layer 2 architecture from the ground up — compliance-native: AI audit trail, citation engine, Human-in-the-Loop by design.
traqx is built to survive the audit, not the demo. Human-in-the-Loop is not a feature — it's the architecture. Citation, audit trail and data residency aren't add-ons; they're load-bearing.
Every AI action is logged, signed and tamper-evident. Every reviewer keystroke too. The regulator gets one log, not three.
The AI proposes; the human disposes. Every claim is cited; every signature is a real signature. No autonomous compliance — ever.
Data stays in EU regions. No model training on your data. Schrems II–compatible. ISO 27001 and SOC 2 attestations on the roadmap.
Three deep-dive case studies. Each one paired to a specific role, anchored to a real Pharma situation, with hard numbers. Read inline. Download as PDF. No sign-up.
Monday morning · blank URS template · 120 pages due Friday. How traqx flipped the workflow from writing to reviewing — every claim cited, every approval signature-bound, audit trail built as you work.
Q3 2027 · ECC end-of-life · 14 global factories · 700 SOPs to assess manually. How traqx's SOP Impact Assessment ranked all 700 by confidence — and Edit-Mode rewrote the 47 that mattered, in your house style.
Global rollout · Factory 1 took 18 months · then traqx's Template ↔ Factory bidirectional model arrived. Local deltas, central audit trail anchored to Template version ID, zero manual reconciliation. Factory N+1 in 30% the time.
Pick the document currently costing you the most: a URS that takes three days, the periodic-review backlog you dread every December, the SaaS vendor qualification that drags six weeks. We'll run it through traqx in a 6-week pilot — on your templates, your SOPs, with your team in control of every signature. If we don't compress the cycle by 60%, you walk away — no questions asked.