Templates and governing context
Word or Excel templates, SOPs, policies and project sources
USE CASE · CAPA
One CAPA case, connected — from trigger to effectiveness.
traqx prepares root cause, actions and the effectiveness check from SOPs, policies and your CAPA template — with sources, open points and a human decision.
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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.
THE CONNECTED EVIDENCE PATH
One CAPA case, connected end to end — from the documented trigger to the audit trail.
Five visible stations. One continuous CAPA case.
01 · SOURCE SPACETrigger and sources in one context
A documented deviation is the trigger: traqx connects it with applicable CAPA SOPs, policies and your template in the controlled source space. That frame limits the groundwork to controlled inputs.
02 · CITATION CHECKCauses evidenced, gaps stay open
traqx structures known facts and potential causes with a visible basis. Every statement is checked deterministically against the sources; missing or conflicting information stays visible as open values.
03 · WORD OUTPUTThe CAPA draft arrives as a Word file
Root cause, actions, owners, deadlines and the effectiveness check sit in your existing template — as tracked changes your team keeps editing directly in Word.
04 · HUMAN REVIEWThe expert decides on every entry
Source and rationale comments sit on the prepared entry itself. The accountable expert corrects, accepts or rejects — formal approval follows your established CAPA process.
05 · AUDIT TRAILThe chain stays traceable
Which cause, action and effectiveness check was reviewed and decided by whom, and when, is in the audit trail — filterable and exportable when the auditor asks.
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.
01
SourceGROUNDThe governing SOP, policy, template or project source stays connected.
02
StatusVERIFYProposals, open points and missing evidence remain distinguishable.
03
HumanDECIDEThe accountable expert reviews and decides in the responsible quality process.
OPERATIONS & SYSTEM FIT
No second CAPA system — your quality process stays in the lead.
- Your QMS remains the leading systemFormal CAPA approval stays where it is. traqx prepares the documentation and makes sources, changes and open points visible — review and decisions happen in the responsible quality process.
- The handover is a Word fileThe result is a .docx in your existing CAPA template — with tracked changes and source comments. It takes the same review and approval path as any other CAPA.
- Your team maintains the sourcesYou decide which SOPs, policies, process and case data form the controlled context. EU-hosted; your documents are not used for model training.
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 a direct work case in traqx — from controlled sources to a reviewable Word version.
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 personal live demo we clarify your template, governing SOP or policy and concrete task — and show the document workflow directly in the system.
Book your personal live demo
No obligation · personal · straight in the calendar