Templates and governing context
Word or Excel templates, SOPs, policies and project sources
USE CASE · Audit readiness · evidence before the audit
Audit-ready while you work — not in the sprint before.
traqx reconciles scope, SOPs and evidence against your source base — hotspots, gaps and owners become visible before the inspection starts.
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THE RECURRING PATTERN
Your context becomes a reviewable document.
The work case uses the same controlled traqx logic as every other document use case.
Research, draft and edit natively
Sources, changes and open points stay connected in the work state.
Audit readiness
The expert reviews and decides; formal approval stays in the responsible process.
Why audit preparation is stressful
The knowledge is rarely missing. It is distributed.
When an inspection draws closer, knowledge is rarely the problem. The problem is <b>distribution</b>: evidence sits in documents, emails, systems and heads. Teams find out too late which gap can become critical — and then prepare the wrong thing under time pressure.
TODAY
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Evidence is everywhere — just not together
SOPs, artefacts, email approvals and unwritten knowledge are spread across systems and heads. Whoever needs the complete evidence path pieces it together from scratch every time.
CONTROL IN traqx
A suggestion stays a suggestion
Hotspots and gap hints live as pending suggestions on the evidence they belong to. Nothing moves into your preparation list without human action — <b>no audit finding writes itself</b>.
TODAY
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The critical gap shows up too late
Which evidence gap really hurts in an audit, the team often only notices in the inspection itself. Preparation runs on gut feeling instead of on a prioritised gap list.
CONTROL IN traqx
Prioritisation as a human review decision
Acceptance, correction or rejection of a classification remains with the expert. traqx documents the person, role, time and rationale of the review decision traceably.
TODAY
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Rationales are written under time pressure
Every hotspot needs a robust rationale with a source reference. If it is only drafted just before the audit, it is thin — and that is exactly what becomes a finding.
CONTROL IN traqx
Source-bound, not fabricated
Hotspots and briefing statements rely only on your approved source pool. Every citation is checked deterministically; a fabricated source is made visible as a <b>warning</b>, not served as audit evidence.
Built for the AI requirements of EU GMP Annex 22: AI prepares the work, your experts review and decide — traceable in the audit trail.
THE CONNECTED EVIDENCE PATH
One upcoming audit, prepared end to end — from scope to audit trail.
One audit case, five visible stations — each works from the state of the one before. Real product views and illustrated system states, synthetic demo data throughout.
01 · SOURCE POOLThe audit scope gets its source pool
You outline the scope of an upcoming audit; relevant SOPs, artefacts and evidence are connected from the controlled libraries. Work is done only with your approved source pool.
02 · GAP SCANScope and evidence are linked through
traqx links scope, SOPs and evidence — the trace view shows what depends on what. Matching against known finding patterns marks hotspots as open points: a preparation aid, not an inspection verdict.
03 · SOURCE CHECKEvery material statement ends on a source
traqx checks every citation deterministically against the sources used. What is evidenced shows its passage; what is missing stays marked as an open gap instead of being silently filled in.
04 · HUMAN REVIEWThe briefing carries its source references
Briefing materials arrive as a Word file with source and rationale comments on the statements. Your experts review, correct and decide — no suggestion becomes the confirmed state without review.
05 · AUDIT TRAILThe prioritisation stays traceable
Who classified which gap and how sits in the audit trail — with person, role, time and rationale. Filterable and exportable when the auditor asks.
By construction
What a traqx audit preparation structurally secures
traqx does not guarantee an inspection outcome and does not declare a company ready by default — the platform supports preparation and evidence management. We only publish real time or hit-rate effects once we have robust real-project or case-study data.
01
Every hotspotsource-boundFrom scope mapping to the briefing material, every hotspot carries its source — clickably traceable, by a human confirmed. Less manual look-up, more robust rationales in the audit.
02
Scope listgaps prioritisedLinked through from the audit scope to the preparation list with owners — the critical gap becomes visible earlier, instead of surfacing in the inspection. Preparation follows the priority, not the gut feeling.
03
0silent AI commitmentsNo hotspot or gap classification enters confirmed audit preparation without human review. By construction — not by discipline. So you go into the inspection more focused.
OPERATIONS & SYSTEM FIT
No second audit management system — your tools continue unchanged.
- traqx handles the substantive preparationScope, evidence, open points and draft answers take shape in traqx. Audit scheduling, findings and CAPA continue unchanged in your existing tools.
- The handover is a Word fileBriefing materials and draft answers arrive as a .docx with source and rationale comments — they follow the same review and approval path as any other document. Approval stays with you.
- The source pool stays under your controlYou decide what sits in the approved source pool — verifiably deletable on request. EU-hosted, no model training on your documents.
Audit readiness software · Pharma
How does AI software support GxP audit preparation?
Audit readiness software turns the audit scope, SOPs, evidence and open points into a reviewable work item. traqx prepares answers and work packages with their sources; QA prioritises, corrects and decides. The preparation is structured, but that does not automatically make a company audit-ready or predict the inspection outcome.
FAQ
Common questions on audit readiness
What does audit readiness mean?
Being able to answer at any time: keeping evidence, justifications and versions in a state where an inspection can verify them without a search operation. Audit readiness is not a project before the audit — it is a state that emerges from daily work, or doesn't.
How do you prepare for a GxP audit?
With a gap analysis along the relevant requirements, consolidated evidence and briefed owners. The biggest lever sits earlier: when sources, versions and approvals stay connected continuously, preparation shrinks from a search operation to a review.
Which documents do auditors request most often?
Typically validation documentation, SOPs with training records, change and deviation history (change control, CAPA), audit trails and supplier assessments. What counts is less the volume than the traceability: where does the statement come from, who approved it when, and on what basis?
How does AI help with audit preparation?
It searches large document sets for gaps and contradictions, then drafts answers with a direct link to the source. QA reviews, corrects and prioritises. Those decisions remain documented at the relevant work item. The result is an evidenced gap list rather than a judgement based on gut feeling.
Is traqx a classic audit management system?
traqx handles the substantive preparation: scope, evidence, open points and draft answers. Your existing tools for audit scheduling, findings and CAPA continue unchanged.
How do AI-generated audit answers remain source-bound?
AI-generated audit answers remain source-bound when every material statement points to a specific source location and that link is checked deterministically against the source before output. In traqx, QA can inspect the source directly, correct the draft and remove unsupported or open points before use. Technical approval remains human.
ONE PRODUCT · ONE REAL DOCUMENT
Evaluate it on your own audit case.
In the personal live demo we clarify your template, governing SOP or policy and concrete task — and show the document workflow directly in the system.
Book your personal live demo
No obligation · personal · straight in the calendar