Templates and governing context
Word or Excel templates, SOPs, policies and project sources
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USE CASE · CSV · GAMP 5 / CSA
Included · no module feeCSV documents without review friction.
URS, specifications, tests and traceability take shape along your SOPs and templates — with source, version and a traceable requirement.
HUMAN REVIEWOpen · expert decision required
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
URS, FS, test cases and the traceability matrix repeat the same substance in four formats. Every inconsistency between them is an audit finding in the making.
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
Retrieval reach is limited to your approved source pool. Every citation is checked deterministically against that pool; a fabricated source is made visible as a warning, not served as truth.
How traqx maps your validation
traqx maps your validation process — whether V-model or agile.
traqx uses your validation SOPs, templates and source spaces to pre-structure documents, make source references visible and keep review decisions traceable. The core principle always stays the same: Policy → SOP → Template. No templates of your own yet? You start with our best-practice templates. Ground · Generate · Verify · Human Review, from URS to PQ. The steps below show the classic V-model — agile cycles follow the same principle.
- 01Step 00
GxP assessment & GAMP category
Before the first line: a structured assessment clarifies GxP relevance and GAMP category. traqx can pre-fill answers as a suggestion. Your experts review, correct and decide; traqx documents the person, role, time and rationale of that review decision.
Review decision traceable · formal signature in the leading QMS - 02Step 01
URS — User Requirement Specification
traqx reads your SOPs, user and functional requirement documents and drafts the requirements block by block. Each generated block is a suggestion that stands beside its source — until you accept, change or reject it.
Deliverable from versioned templates, every block evidenced - 03Step 02
FS — Functional & risk specification
From the expert-reviewed URS, traqx derives the functional specification — consistent with the source, not reinvented. For table blocks you see a row- and cell-level diff: what is added, removed, changed.
Row-level diff for tabular blocks, evidenced against the URS - 04Step 03
IQ / OQ — Installation & Operational Qualification
Test cases come from the specified requirements, back-linked via traceability. Every statement of regulatory relevance ends on a clickable source — a fabricated citation fails the deterministic check.
Deterministic citation check: pass / fail - 05Step 04
PQ — Performance Qualification
Performance Qualification confirms the system in your environment — it remains a tenant-specific activity that traqx supports in a structured way but does not own for you. A formal PQ standard procedure is in development.
PQ tenant-specific · formal procedure in development - 06throughout
Human Review — Audit trail
Across all phases the audit trail documents the person, role, time, change and rationale of the review decision. Formal process release or e-signature takes place in the leading QMS or another responsible system.
Review traceable · formal release in the leading QMS
By construction
What a CSV workflow structurally secures
CSV is available out of the box today. We only publish real time or cost effects once we have robust real-project or case-study data.
From 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.
One requirement, 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.
No suggestion enters the reviewed work package without human review. By construction — not by discipline. So QA review and inspection preparation start from clearer evidence.
AI preparesresearch · drafts · updates · candidate traces
Experts verifycorrectness · correction · acceptance · decision
traqx makes visiblesource · status · change · review path · audit trail
Customer data stays protectedagreed tenant and hosting scope · no model training on customer data
AI-powered Computer System Validation software
What does AI-powered CSV software do — and what remains with Quality?
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
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