Controlled document, validation and evidence work
Your team works with defined sources, needs reviewable drafts or updates and retains subject-matter assessment and decision with the accountable expert.
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PHARMA · ORGANISATIONAL FIT
AI for pharmaceutical quality teams: where traqx fits.
traqx fits a pharmaceutical quality team when controlled sources for SOP, validation, qualification or audit work need to be brought together and used to prepare reviewable groundwork. traqx replaces neither the existing eQMS nor the DMS and makes no autonomous QA or release decision.
THREE CONCRETE SITUATIONS
How traqx prepares groundwork in pharmaceutical quality work.
Each situation starts with controlled inputs and ends with a reviewable result. The responsible expert retains assessment and decision-making.
Revise an existing SOP with a visible rationale
CONTROLLED INPUTS
Existing manufacturing SOP, applicable quality policy, current company template and documented reason for change.
AGENT TASK
SOP Agent · Compares the SOP, requirements and template and prepares a justified revision.
REVIEWABLE RESULT
Word file with tracked changes, source and rationale comments, and an updated version history.
HUMAN / SYSTEM BOUNDARY
The customer reviews and releases the SOP through its own quality process; traqx does not set a release status.
Review connected validation documents after a system change
CONTROLLED INPUTS
Documented change to a GxP IT system, plus the affected URS, approved risk assessment, test specification and current trace matrix.
AGENT TASK
Validation Agent · Compares the connected documents and marks deviations and missing links that require subject-matter review.
REVIEWABLE RESULT
Deltas, a gap list and traceability candidates tied to the controlled inputs.
HUMAN / SYSTEM BOUNDARY
The validation expert assesses relevance and adequacy and decides on changes and tests.
Prepare one concrete audit or inspection question
CONTROLLED INPUTS
One documented question, approved site SOPs, selected qualification records and the related project evidence.
AGENT TASK
Audit Agent · Researches only inside the approved source room and separates evidenced statements from open points.
REVIEWABLE RESULT
Cited answer draft, evidence list and clearly identified open points.
HUMAN / SYSTEM BOUNDARY
The expert reviews the answer and evidence; traqx neither assesses the audit or inspection nor predicts its outcome.
CONTROLLED WORKING MODEL
traqx prepares. Your pharmaceutical expert decides.
The defined source room limits the groundwork. Source, status and open points remain visible on the work object.
- 01 · SCOPE
Define relevant sources
Policies, SOPs, templates, project files and external requirements are scoped for the concrete work object.
Result · defined source room - 02 · GENERATE
Prepare research and draft
traqx researches inside the source room, creates drafts and suggests document updates or traces.
Result · reviewable suggestion - 03 · VERIFY
Check source references and open points
Evidence passages, status and gaps remain visible; source verification remains a separate control step.
Result · evidenced or open point - 04 · REVIEW
Review as the accountable expert
Experts correct, accept or reject. Formal release still follows the accountable quality process.
Result · human decision
FIT / BOUNDARY
A fit when groundwork needs control. Not a fit as a system replacement.
Product fit includes a bounded source room, a reviewable result, human review and a clear boundary to existing systems.
OPTIONAL PROCESS EXTENSION: A separately bookable GxP module is only added when a recurring process also needs a preconfigured method, templates, defined work objects and a review path. When a GxP module is added →
eQMS, DMS or autonomous QA
traqx does not replace a quality or document system of record, make an autonomous QA decision or promise blanket formal release.
PRODUCT EVIDENCE, NOT A REFERENCE CLAIM
Inspect the control logic in a visible system state.
traqx is EU-hosted and works in controlled source rooms; customer documents stay within the agreed tenant and hosting scope and are not used for model training. Experts review and decide. The product dossiers show real system views with synthetic demo data—not customer outcomes.
Trust Architecture → View product dossiers →VISIBLE PRIMARY SOURCES
Pharmaceutical statements stay in the actual GMP context.
- European Commission · EudraLex Volume 4
The official collection of EU GMP guidelines. It is used here to frame the process actually subject to GMP, not as a blanket compliance seal for software.
- EU GMP Chapter 4 · Documentation
The current Chapter 4 text frames documentation in the GMP context. This page infers neither automatic release nor replacement of an eQMS from it.
FAQ
Pharmaceutical fit without shortcuts in the proposition.
Is traqx a fit for a pharmaceutical quality team—and does it replace the existing eQMS or DMS?
traqx fits a pharmaceutical quality team when controlled sources for SOP, validation, qualification or audit work need to be brought together and used to prepare reviewable groundwork. traqx replaces neither the existing eQMS nor the DMS and makes no autonomous QA or release decision.
How does an SOP revision remain reviewable in Word?
traqx can return the updated file with tracked changes, source and rationale comments, and an updated version history. The responsible expert reviews the change and releases it through the existing quality process.
How does traqx help after a change to a GxP IT system?
traqx can compare affected requirements, risks, tests and traces as controlled sources and prepare deltas, gaps and traceability candidates. The validation expert assesses relevance and decides on changes and tests.
Who is responsible for formal release?
Release remains with the customer and follows its existing quality process. traqx makes sources, changes, status and open points reviewable but does not set a draft to released on its own.
FRAME THE PHARMACEUTICAL PROCESS
Bring one real work object.
In the meeting, we show the source room, agent task, review and system boundary on your real work object.
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