traqxGxP Compliance Software
All use cases →

USE CASE · INCLUDED IN traqx

Included · no module fee

CAPA

Prepare CAPA documentation from the event, governing SOPs, process context and your template.

traqxWORK CASE · REVIEW STATE
CAPA · product view in traqx
Real product view · synthetic demo data
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.

01 · INPUT

Templates and governing context

Word or Excel templates, SOPs, policies and project sources

02 · traqx

Research, draft and edit natively

Sources, changes and open points stay connected in the work state.

03 · OUTPUT

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.

01
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.

02
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.

03
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.

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.

  1. 01
    01 · 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
  2. 02
    02 · 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
  3. 03
    03 · GENERATE

    Document actions and effectiveness checks

    Owners, deadlines, actions and review criteria are prepared in the existing template.

    Result · CAPA document draft
  4. 04
    04 · 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.

01SourceGROUND

The governing SOP, policy, template or project source stays connected.

02StatusVERIFY

Proposals, open points and missing evidence remain distinguishable.

03HumanDECIDE

The accountable expert reviews and decides in the responsible quality process.

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

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.

ONE PRODUCT · ONE REAL DOCUMENT

Clarify this use case for your document.

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.

Book a meeting & start free