PHARMA · DOES IT FIT US?

traqx prepares validation (CSV), SOPs and inspections with evidence.
The decision stays with your experts.

traqx brings your controlled sources together and prepares reviewable results — for SOPs down to a Word file with tracked changes and rationale comments. Assessment and release stay in your quality process.

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WHAT YOUR TEAM GAINS

Your experts review prepared results — instead of compiling raw material.

Drafts arrive with evidence
Every proposal shows source, status and open points directly on the work object.
SOPs stay reviewable in Word
Tracked changes, rationale comments and version history — reviewed and released in your existing quality process.
Release stays in your quality process
traqx sets no release status; assessment and decision stay with your experts.

THREE CONCRETE SITUATIONS

How traqx prepares groundwork in pharmaceutical quality work.

Each situation leads from controlled inputs to a reviewable result — assessment and decision stay with the responsible expert.

Validation Agent (digital assistant) · product view in traqx

01Review CSV/CSA documentation after a system change

WHAT YOU PUT INYou changed something on a GxP IT system: the documented change, plus the affected requirements list (URS), approved risk assessment, test specification and current trace matrix.

WHAT TRAQX DOESValidation Agent (digital assistant) · Compares the connected documents and marks deviations and missing links that require subject-matter review.

REVIEWABLE RESULTA list of the differences, the missing points and the places still to be linked (traceability) – each with a reference to your approved documents.

WHAT YOUR TEAM DECIDESThe validation expert assesses relevance and adequacy and decides on changes and tests.

02Revise an existing SOP with a visible rationale

WHAT YOU PUT INExisting manufacturing SOP, applicable quality policy, current company template and documented reason for change.

WHAT TRAQX DOESSOP Agent (digital assistant) · Compares the SOP, requirements and template and prepares a justified revision.

REVIEWABLE RESULTThe revised manufacturing SOP as a Word file — changes tracked, sources and rationale commented, history maintained.

WHAT YOUR TEAM DECIDESThe customer reviews and releases the SOP through its own quality process; traqx does not set a release status.

03Prepare one concrete audit or inspection question

WHAT YOU PUT INOne documented question, approved site SOPs, selected qualification records and related project evidence.

WHAT TRAQX DOESAudit Agent (digital assistant) · Researches only inside the approved source room and separates evidenced statements from open points.

REVIEWABLE RESULTCited answer draft, evidence list and clearly identified open points.

WHAT YOUR TEAM DECIDESThe expert reviews the answer and evidence; traqx neither assesses the audit or inspection nor predicts its outcome.

The defined source room limits the groundwork — source, status and open points stay visible on the work object.

01SCOPEDefine relevant sources
Policies, SOPs, templates, project files and external requirements are scoped for the concrete work object.
Result · defined source room
02GENERATEPrepare research and draft
traqx researches inside the source room, creates drafts and suggests document updates or traces.
Result · reviewable suggestion
03VERIFYCheck source references and open points
Evidence passages, status and gaps stay visible; source verification remains a separate control step.
Result · evidenced or open point
04REVIEWReview as the accountable expert
Experts correct, accept or reject; formal release follows your quality process.
Result · human decision

FITS / DOES NOT FIT

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.

✓ FITS

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.

— DOES NOT FIT AS

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.

EVIDENCE, NOT A MARKETING 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.

View practice case & product dossiers →Trust System →

VISIBLE PRIMARY SOURCES

Where our pharmaceutical statements come from: the official EU GMP texts.

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 CSV/CSA, SOP, 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.

traqx prepares validation (CSV), SOPs and inspections with evidence.The decision stays with your experts.

Your experts review prepared results — instead of compiling raw material.

How traqx prepares groundwork in pharmaceutical quality work.

Mapped traqx use cases for this industry.

CSV / CSA

SOP management

Audit readiness

Change Control

CAPA

Equipment qualification

Process validation / CPV

Supplier Assessment

IT infrastructure qualification

Cleanroom / Annex 1

traqx prepares. Your pharmaceutical expert decides.