CAPA · EU GMP / ICH Q10 In development
Make CAPA effectiveness provable.
Cause, action, owner, effectiveness check and evidence are run as one continuous chain.
Relevant to EU-GMP, ICH Q10 and 21 CFR Part 11.
- Don't just tick off effectiveness — in the audit you show the cause is gone.
- Tie cause and action back together — source-bound, with human approval.
- Bring evidence together under control — value and workflow are in preparation; in the joint build-out we create the CAPA discipline on your process.
CAPA lifecycleICH Q10 · ALCOA+
Deviation captured · planned, in preparation
Why CAPA gets flagged in the audit
Actions get done. The link is missing.
In practice, CAPA often ends as a list of completed tasks. What counts in the audit — the traceable chain from the cause through the action to evidenced effectiveness — lies scattered across tickets, emails and spreadsheets. The more deviations, sites and systems are involved, the harder a consistent record becomes.
01
Action without an evidenced cause
Corrective actions are defined before the root cause is cleanly structured. In the audit it then cannot be shown why exactly this action addresses the cause.
02
Owners and deadlines get lost
Owners and dates live in separate tools. Who is responsible for which action by when — and whether it was really closed — can only be reconstructed by asking around.
03
Effectiveness stays unevidenced
The effectiveness check is announced but rarely documented in a way that ties back to cause and action. The evidence that the problem was really solved is missing — or has to be assembled late.
How traqx should map CAPA
From deviation to evidenced effectiveness — as one continuous chain.
The core principle stays the same as everywhere in traqx: Policy → SOP → Template. traqx should use your CAPA SOPs, templates and source spaces to pre-structure the steps, make source references visible and keep every decision traceable. The following steps describe the planned workflow — this use case is in preparation and will be built together on your real process.
Why this should hold up in the audit
The AI structures. You stay accountable.
For CAPA too the traqx core principle applies: no AI output is silently written into a validated record. Until your approval, every proposal stays a proposal — and only your confirmation makes a record true. This architecture is built; the CAPA workflow on top of it is in preparation.
By construction
What a linked CAPA workflow should structurally secure.
Cause → effectiveness
linked through
Cause, action, owner, deadlines and effectiveness check should stay linked as one chain — instead of living in separate tools. The audit question “why this action?” becomes answerable on the record.
Evidence
arises with
Evidence should arise with the work, not be assembled afterwards. Every step carries its source and approval — less late searching, more consistent inspection readiness.
0
silent AI writes
No proposal should enter the record without human approval. By construction — not by discipline. This principle is built platform-wide; the CAPA workflow on top of it is in preparation.
Status: in preparation. This use case is not yet available — value and workflow are planned, not a live feature. The structural properties shown here describe the planned discipline on the existing traqx architecture; no guarantee of an audit outcome, but better preparation. We publish reliable time or cost effects only with real pilot or case-study data.
Questions from practice
Common questions on CAPA
What does CAPA mean?
Corrective and Preventive Action: understanding the cause of a quality problem (root cause), implementing effective actions and evidencing their effectiveness. CAPA is the process that turns deviations into improvement — traceable and documented.
What is the difference between correction, corrective action and preventive action?
The correction fixes the immediate symptom. The corrective action removes the cause so the problem does not recur. The preventive action prevents the same cause from becoming a problem elsewhere. Inspectors check whether all three are cleanly distinguished and evidenced.
Why do CAPA processes fail in practice?
Superficial root-cause analyses, actions without effectiveness checks, and evidence scattered across systems and inboxes. The result: recurring deviations — and CAPA findings in the next audit.
How does AI support the CAPA process?
With structured drafts for root-cause analysis, action plan and effectiveness assessment from your controlled sources — every statement evidenced. Assessment, decision and approval stay with your team; owners and deadlines stay connected instead of scattered.
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
Help shape CAPA with us.
CAPA is in preparation — and that is exactly why now is the right moment. Bring a real CAPA process along and build the discipline with us on your standard, instead of having a finished template imposed on you.
No sales pitch — a short conversation around your concrete CAPA scope. CAPA stays clearly marked as a roadmap use case; we assess together whether a joint build-out makes sense. The assessment is yours even if you say no afterwards; source room deleted on request with evidence.