Templates and governing context
Word or Excel templates, SOPs, policies and project sources
All use cases →
USE CASE · INCLUDED IN traqx
Included · no module feeCAPA
Prepare CAPA documentation from the event, governing SOPs, process context and your template.
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Registration → 15-minute intro call → personal activation
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.
CAPA
The expert reviews and decides; formal approval stays in the responsible process.
CAPA DOCUMENTATION
Actions get completed. The connection gets lost.
CAPA becomes difficult to review when cause, action, owner, deadline, effectiveness check and evidence live in separate files or systems.
TODAY
→
Cause and action are not tied together
The plan says what will be done, but not reliably which documented cause the action addresses.
CONTROL IN traqx
Cause and action in one context
traqx prepares both from controlled sources inside the intended CAPA template.
TODAY
→
The document state is distributed
SOPs, case data, templates and evidence have to be assembled and checked for consistency manually.
CONTROL IN traqx
SOPs, policies and template connected
The source room limits the groundwork; missing or conflicting information remains open.
TODAY
→
Effectiveness remains abstract
The criterion, timing and evidence for the effectiveness check are not clearly connected to cause and action.
CONTROL IN traqx
Effectiveness check as a reviewable draft
Criterion, timing and evidence are prepared but assessed and confirmed by the expert.
Built for the AI requirements of EU GMP Annex 22: AI prepares the work, your experts review and decide — traceable in the audit trail.
CAPA IN traqx
From a documented trigger to a reviewable CAPA draft.
Your CAPA template defines the structure. SOPs, policies and process or system context provide the basis. traqx prepares; your team reviews and decides.
- 0101 · GROUND
Define the trigger and source room
The deviation, complaint or other trigger is connected with applicable CAPA SOPs, policies and the template.
Result · controlled context - 0202 · ANALYSE
Prepare the root-cause structure
traqx structures known facts, missing information and potential causes as a proposal with a visible basis.
Result · reviewable analysis draft - 0303 · GENERATE
Document actions and effectiveness checks
Owners, deadlines, actions and review criteria are prepared in the existing template.
Result · CAPA document draft - 0404 · REVIEW
Review and decide professionally
The accountable expert corrects, accepts or rejects. Formal approval follows the established CAPA process.
Result · human decision
REVIEW CRITERIA
Useful only when the work state is reviewable.
No autonomous quality decision or formal release: traqx prepares document work; the accountable expert decides.
The governing SOP, policy, template or project source stays connected.
Proposals, open points and missing evidence remain distinguishable.
The accountable expert reviews and decides in the responsible quality process.
DOCUMENT USE CASE · INCLUDED IN traqx
How does traqx support CAPA?
traqx uses the documented trigger, applicable SOPs, policies, process context and your CAPA template as controlled inputs. It prepares root-cause analysis, the action plan, owners, deadlines and the effectiveness check as a reviewable document draft. Your team reviews, corrects and decides; formal CAPA approval stays in the responsible quality process.
FAQ
Frame CAPA with traqx clearly.
Is CAPA included in traqx?
Yes. Document-based CAPA work is part of traqx and carries no separate module fee.
Which inputs does traqx need?
At minimum, a documented trigger, the applicable SOPs or policies and the CAPA template in use. Process, system and case data extend the controlled context.
Does traqx formally approve a CAPA?
No. traqx prepares documentation and makes sources, changes and open points visible. Review and formal approval remain in the responsible quality process.
What belongs in a CAPA process description?
A robust internal CAPA process description should define triggers, roles, structured root-cause analysis, actions, deadlines, effectiveness checks and closure criteria. ICH Q10 describes a structured, risk-proportionate and documented investigation process to determine root cause; in commercial manufacturing, action effectiveness should be evaluated. traqx prepares this chain from your released sources; review and approval stay with your team.
ONE PRODUCT · ONE REAL DOCUMENT
Evaluate it on your own CAPA case.
In the 15-minute introductory call, we clarify your template, governing SOP or policy and concrete task. If a product walkthrough is the right next step, we arrange it separately.
Start free now →
Registration → 15-minute intro call → personal activation