Templates and governing context
Word or Excel templates, SOPs, policies and project sources
USE CASE · Computer system validation (CSV) · GAMP 5 / CSA
Validation, review-ready from the first draft.
The evidence that your system reliably does what it should: traqx prepares requirements (URS), specifications, tests – and the proof that everything fits together (traceability) – from your SOPs, templates and project sources — every block source-bound, every decision with your experts.
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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.
CSV / CSA
The expert reviews and decides; formal approval stays in the responsible process.
Why CSV takes so long
It is not the validation that costs time. It is everything around it.
The V-model is proven. What slows projects down: the same rationales, requirements and traceability links are searched for, phrased and reviewed again and again. The more systems, templates and sites are involved, the harder it becomes to keep a consistent standard.
TODAY
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Knowledge lives in heads, not in the system
Validation projects often hinge on individual experts. When that person leaves, the knowledge leaves — and every follow-up project starts almost from scratch.
CONTROL IN traqx
A suggestion stays a suggestion
AI values live as pending suggestions on the block they belong to. The stored content stays unchanged until a human acts — no unattended document fills itself.
TODAY
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The same requirement, rewritten five times
The same requirement ends up in four documents – requirements (URS), specification (FS), test cases, traceability matrix. Every deviation between them gets flagged at the next audit.
CONTROL IN traqx
Human review with a traceable decision
Acceptance, correction or rejection remains with the expert. traqx documents the person, role, time and rationale of the review decision traceably.
TODAY
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Evidencing is manual work
Which SOP, which clause of the standard backs this requirement? In review it is looked up line by line by hand — late, laborious and error-prone.
CONTROL IN traqx
Source-bound, not fabricated
traqx searches only inside the source pool you have approved. Every citation is checked deterministically against that pool; a fabricated source is made visible as a warning, not served as truth.
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 Computer System Validation, evidenced end to end — from URS to audit trail.
Five stations, one connected work state.
01 · SOURCE SPACEThe source space comes from your libraries
Validation SOPs, templates and project sources form the source space for this system. traqx searches only the sources you have approved — nothing else flows in.
02 · DRAFTINGThe agent drafts section by section: first the URS, then the FS
Drafts from your SOPs and requirement documents — each block a source-bound suggestion until your expert accepts, changes or rejects it. A fabricated citation fails the deterministic check.
03 · WORD OUTPUTThe work state returns as a Word file
URS and FS return with tracked changes: your reviewer sees old and new directly in Word and can edit every suggestion — the file takes the usual review path.
04 · HUMAN REVIEWAccepted and Pending stay clearly separate
Requirements, risks and tests are connected row by row as traces. Your expert confirms or rejects the technical relationship — documented with person, role, time and rationale.
05 · AUDIT TRAILEvery decision stays traceable
From URS to test case, the audit trail records every review decision — person, role, time, rationale. For an inspection it can be filtered and exported.
By construction
What a CSV workflow structurally secures
CSV is ready to use today. We only publish real time or cost effects once we have robust real-project or case-study data.
01
Reviewed blockssource-boundFrom the URS to the test case, every block carries its source — clickably traceable, confirmed by a human. On changes, delta review instead of full review: what is reviewed is what changed.
02
1 NTraceabilityOne requirement, findable everywhere — linked through from URS via FS to the test case — the traceability matrix is built along the way instead of being pieced together afterwards. The standard lives in the agent, not just in the senior's head.
03
0changes without your approvalNo suggestion enters the reviewed work package without human review. By construction — not by discipline. So QA review and inspection preparation start from clearer evidence.
OPERATIONS & SYSTEM FIT
No second regulated system — your release stays in the leading QMS.
- Your QMS remains the leading systemtraqx produces a reviewable work package, not an automated validation decision. Formal process release and e-signature stay in the leading QMS or another responsible system.
- The work package is a Word fileURS and specifications reach your reviewers as a .docx with tracked changes and source comments — the URS/FS package is reviewed in Word and released in the familiar process.
- Documentation for your own validationYou remain responsible for validating traqx for your use — so your team does not start from zero, we provide the documentation up front: deterministic source check, audit trail, EU hosting, no model training on your data. Final release stays with you.
AI-powered Computer System Validation software
What does AI-powered CSV software do — and what remains with Quality?
In short: the software prepares the validation documents, your experts review and decide. AI-powered Computer System Validation software can prepare URS, specifications, risks, tests and traceability along controlled SOPs, templates and project sources. In traqx, the source, version, status and changes remain visible for review; citations are checked deterministically. The result is a reviewable work package, not an automated validation decision. Quality and the responsible subject-matter roles assess intended use and risk, review the content and evidence, and decide on acceptance and formal approval. EU GMP Annex 11 requires the application to be validated and the IT infrastructure qualified. The FDA CSA guidance describes a risk-based assurance approach for production and QMS software in the medical-device context; it is not a blanket replacement for EU GMP CSV.
FAQ
Common questions on Computer System Validation
What is Computer System Validation (CSV)?
Computer System Validation is the documented evidence that a computerised system in a GxP environment reproducibly does what it is supposed to do — from requirements (URS) through risk assessment and testing (IQ/OQ/PQ) to attributable approval. The governing frameworks are GAMP 5, EU GMP Annex 11 and 21 CFR Part 11.
What is the difference between CSV and CSA?
Computer Software Assurance (FDA final guidance) shifts the focus from documentation volume to risk-based testing depth: critical functions are tested deeply, uncritical ones leanly. CSV remains the framework — CSA determines how deep you test. The details: CSA vs. CSV.
What distinguishes AI for CSV from classic validation software?
AI for CSV handles substantive work across several validation artefacts: it evaluates sources, prepares URS, FS, risks and tests as connected drafts, builds traceability and keeps changes visible. Classic validation software often organises documents, tests and approvals. traqx replaces neither the technical review nor formal approval; the expert decides in the existing process.
Can AI create validation documents?
Only under clear conditions. Intended use, risk and the regulated process determine where AI is appropriate. GAMP 5 Second Edition addresses AI/ML explicitly. The Annex 22 draft excludes Generative AI from critical GMP applications; for non-critical applications, adequately qualified and trained personnel remain responsible for output suitability. traqx provides a controlled draft with visible source and status for that review.
How long does Computer System Validation take?
There is no standard duration; risk class and system scope set the pace. In practice it is rarely the testing itself that costs time, but manually holding together documents, reviews and traceability. With clearly phased steps and source-bound drafts the process becomes predictable — without losing testing depth. A phased plan: this guide.
Can traqx update an existing URS after a meeting or change?
Yes. The agent checks the new decision against the project sources and connected documents, then identifies the affected sections. In the revised Word file, the new wording appears as a tracked edit. A comment names the source and explains the proposal. The result can be reviewed like any other technical revision in Word.
How does AI-generated traceability remain reviewable?
traqx connects requirements, risks and tests row by row as traces. Accepted and Pending remain clearly separate. Citations are checked against the sources used; an expert confirms or rejects the technical relationship.
ONE PRODUCT · ONE REAL DOCUMENT
Evaluate it on your own CSV 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