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USE CASE · Cleanroom · Annex 1
Included · no module feeCleanroom evidence that carries through the cycle.
traqx links classification, monitoring, deviations and requalification along your cleanroom SOPs.
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.
Cleanroom / Annex 1
The expert reviews and decides; formal approval stays in the responsible process.
Why qualification status trembles before audits
It's not the qualification that's missing. It's the evidence logic.
A room is qualified — but <em>why</em> 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.
TODAY
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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.
CONTROL IN traqx
A suggestion stays a suggestion
AI values live as pending suggestions on the evidence they belong to. The stored qualification status stays unchanged until a human acts — no room counts automatically as qualified.
TODAY
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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.
CONTROL IN traqx
Human review with a traceable decision
Acceptance, correction or rejection of evidence remains with the expert. traqx documents the person, role, time and rationale of the review decision traceably.
TODAY
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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.
CONTROL IN traqx
Source-bound, not freely invented
Retrieval reach is limited to your approved source pool — classification reports, monitoring data, SOPs. Every citation is checked deterministically against this pool; an invented source is surfaced as a warning, not output as truth.
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. Ground · Generate · Verify · Human Review, from classification to the human decision.
- 01Step 01
Capture room, class, scope & qualification status
traqx captures room, cleanroom class, qualification scope and current status in structured form — the basis against which every further piece of evidence is linked. You confirm what holds.
Structure from versioned templates, confirmed by a human - 02Step 02
Connect SOPs, plans & monitoring evidence
Relevant SOPs, qualification plans and monitoring evidence are connected to the room — every link stays source-bound and clickably traceable, not freely asserted.
Source-bound, limited to your approved pool - 03Step 03
Prepare qualification or requalification structure
From the connected requirements traqx pre-structures the qualification or requalification logic — consistent with the source, not reinvented. Every block is a suggestion, until you accept, change or reject it.
A suggestion stays a suggestion until human review - 04Step 04
Link evidence, deviations & open items
Evidence, deviations, trends and open items are linked with the qualification logic. Every statement of regulatory relevance ends on a clickable source — an invented citation fails the deterministic check.
Deterministic citation check: pass / fail - 05Step 05
Surface review questions & responsibilities
Open review questions and responsibilities are kept visible — who closes which gap before an inspection asks about it. Your experts review, correct and decide; person, role, time and rationale remain traceable.
Review decision with person, role, time and rationale - 06throughout
Hold human review & audit trail
Across all steps the audit trail documents the person, role, time, change and rationale of the review decision. Formal qualification 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 cleanroom qualification structurally safeguards
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 real-project or case-study data.
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.
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.
No suggestion enters the reviewed qualification work package without human review. By construction — not by discipline. So requalification 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
Cleanroom qualification under Annex 1
How does software support cleanroom qualification under Annex 1?
Cleanroom qualification software should keep rooms, grades, the CCS, qualification documents and monitoring evidence in one connected view. traqx prepares a source-bound work package for qualification and requalification, with missing evidence and open decisions kept visible. The responsible team still determines classification and qualified status.
FAQ
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. QA reviews, corrects and decides; traqx documents the person, role, time and rationale of the review decision. Formal release or e-signature takes place in the leading QMS or another responsible system.
ONE PRODUCT · ONE REAL DOCUMENT
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