Cleanroom · Annex 1
Cleanroom evidence that carries through the cycle.
traqx links classification, monitoring, deviations and requalification along your cleanroom SOPs.
Relevant to EU-GMP Annex 1 and qualification evidence.
- Bring CCS and evidence together visibly.
- Stop reconstructing status again and again.
- The decision stays a human responsibility.
Cleanroom lifecycleEU-GMP Annex 1 (2022)
Room, class & scope captured · structure confirmed by a human
Why qualification status trembles before audits
It's not the qualification that's missing. It's the evidence logic.
A room is qualified — but why it is, is spread across classification reports, monitoring data, deviations, trends and SOPs. Before an inspection this rationale often has to be laboriously reassembled. The more rooms, classes and requalification cycles, the harder it becomes to hold a consistent, robust record.
01
The evidence is scattered, not linked
Classification, monitoring, deviations and SOPs live in separate repositories. Which evidence exactly supports the status of a room is not apparent at first glance.
02
Before the audit, it's reconstructed instead of evidenced
When the inspector asks why a room is qualified, the search begins: reports, trends and deviations are assembled by hand into a rationale — late and under pressure.
03
Open items vanish between cycles
Between qualification and requalification, open items, trend anomalies and due actions are easily lost — until they show up as a gap in the audit.
How traqx models your cleanroom qualification
traqx structures qualification logic, evidence and open items — along your cleanroom SOPs.
traqx uses your cleanroom SOPs, monitoring requirements and source spaces to pre-structure qualification logic, make evidence links 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 classification to the audit trail.
Why this holds up in an audit
The AI structures. You own it.
The AI output is never silently written into a validated dataset. Until you approve it, every evidence link stays a suggestion — and only your confirmation makes the qualification status defensible. Classification and requalification decision remain your regulated responsibility.
By construction
What a cleanroom qualification structurally safeguards.
Every piece of evidence
source-bound
From classification to monitoring evidence, every piece of evidence carries its source — clickably traceable, by a human confirmed. Less laborious reconstruction before the audit, more consistent evidence logic.
Status → evidence
linked through
The qualification status of each room is linked with the evidence that supports it — the rationale is created with, instead of being assembled before the inspection. Gaps become visible earlier.
0
silent AI writes
No suggestion lands without human approval in the qualification record. By construction — not by discipline. So you go into requalification and inspection better prepared.
Cleanroom qualification is available today as soon as your customer-specific cleanroom and monitoring documents are in place. traqx is not a certification and not a guarantee — classification and requalification decision remain your regulated responsibility. We publish real time or cost effects only with robust pilot or case-study data.
Questions from practice
Common questions on cleanroom qualification
What does EU GMP Annex 1 require for cleanroom qualification?
Annex 1 (2022 revision) requires an overarching contamination control strategy, qualification of cleanrooms by grade, ongoing environmental monitoring and documented requalification. The common thread: contamination control must be evidencable as a complete system, not a collection of isolated records.
What is a Contamination Control Strategy (CCS)?
A documented overall concept that connects all technical and organisational contamination controls and evidences their effectiveness — from facility design through personnel flow to monitoring. The CCS is the document inspectors use to read the maturity of your contamination management.
How often must a cleanroom be requalified?
Annex 1 sets maximum intervals of six months for grades A and B and twelve months for grades C and D — shorter cycles follow from risk, for example after changes or notable monitoring trends. Annex 1 and your documented risk assessment govern.
How does AI help with Annex 1 documentation?
It drafts qualification and monitoring reports with source binding to CCS, measurement data and specifications — consistent across rooms and periods. Assessment and approval stay with QA; the audit trail connects measurement, statement and signature.
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 room.
Bring a real cleanroom qualification along to the demo — one room, one class, exactly the evidence logic whose reconstruction holds you back before every audit. First structured drafts appear early in the first process; we set concrete time targets together before the start.
No sales pitch — a short conversation around your concrete cleanroom 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.