CSV · GAMP 5 / CSA
CSV documents without review friction.
URS, specifications, tests and traceability take shape along your SOPs and templates — with source, version and a traceable requirement.
Relevant to GAMP 5, EU Annex 11 and risk-based CSA approaches.
- Every requirement leads back to its source.
- Drafts are prepared review-ready.
- Your team approves, not the AI.
Your validation pathGAMP 5 · CSA-based
Requirements captured at the source
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.
01
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.
02
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.
03
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.
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. Generate · Verify · Monitor, from URS to PQ. The steps below show the classic V-model — agile cycles follow the same principle.
Why this holds up in an audit
The AI drafts. You own it.
The AI output is never silently written into a validated record. Until your approval, every suggestion stays a suggestion — and only your confirmation makes a record true.
By construction
What a CSV workflow structurally secures.
Approved blocks
source-bound
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.
1 → N
Traceability
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.
0
silent AI writes
No suggestion lands in the record without human approval. By construction — not by discipline. So you go into QA review and inspection better prepared.
CSV is available out of the box today. We only publish real time or cost effects once we have robust pilot or case-study data.
Common question
Do I have to validate traqx myself?
Documentation to support your own validation, a deterministic source check, an audit trail and EU hosting — no model training on your data.
The final validation and release in your own QMS remains your responsibility.
Questions from practice
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, last updated February 2026) 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.
Can AI create validation documents?
Yes — under controlled conditions. GAMP 5 Second Edition explicitly addresses AI/ML, and the risk-based FDA CSA approach does not prescribe the tool. The precondition: every statement stays evidenced and a human reviews and approves — source binding, attributable approval, a complete audit trail — the AI draft remains a suggestion until your team approves it. That is exactly how traqx works.
How long does Computer System Validation take?
It depends on risk class and system scope. 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.
More disciplines
One platform, many use cases.
Same trust architecture — sources first, AI as a suggestion, human decides, audit trail stays — across every GxP discipline.
Security & standards · built for traceable evidence
Founded by CSV experts with 15+ years of domain expertise
Start with one system.
Bring a real Computer System Validation along to the demo — one system, one standard, exactly what is slowing you down right now. First generated drafts (URS, risk analysis) take shape early in the first process; concrete time targets we set together before the start.
No sales pitch — a short conversation around your concrete CSV scope. We define success criteria in writing before the start; the documented assessment is yours even if you say no afterwards. EU-hosted, no model training, source room deleted on request with evidence.