Templates and governing context
Word or Excel templates, SOPs, policies and project sources
USE CASE · Change control
Every impact visible before you change.
traqx connects the documented change with SOPs, policies and system context — and prepares the impact assessment, deltas and the change draft with visible sources. Your team assesses and decides.
Book your personal live demo
See traqx →
No obligation · personal · straight in the calendar
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.
Change Control
The expert reviews and decides; formal approval stays in the responsible process.
CHANGE CONTROL DOCUMENTATION
A change rarely affects just one document.
The effort sits in finding affected requirements, risks, tests, SOPs and evidence—and transferring them consistently into the Change Control documentation.
TODAY
→
The impact remains incomplete
Affected documents and dependencies are assembled manually across multiple repositories.
CONTROL IN traqx
Affected artefacts as reviewable candidates
traqx researches inside the bounded source room and shows matches, rationales and open points.
TODAY
→
Rationales lose their source
Why a document or test is affected lives in comments or individual knowledge rather than with the change draft.
CONTROL IN traqx
Source and rationale with the proposal
The reviewer can inspect the basis of an impact proposal and correct or reject it.
TODAY
→
Deltas are transferred repeatedly
Changes move manually between the assessment, risk record, tests and document updates.
CONTROL IN traqx
Deltas inside connected documents
Document updates are prepared in the familiar template with visible changes.
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 IMPACT PATH
One change, its impact evidenced end to end — from source space to audit trail.
Five stations, one continuous case.
01 · SOURCE SPACESOPs, system context, template connected
The change trigger is connected to the controlled libraries: applicable SOPs, policies, system context and your Change Control template form the source space for this case.
02 · IMPACTAffected artefacts become visible
traqx researches inside the bounded source space: requirements, risks, tests, SOPs and evidence appear as linked matches — with rationale and open connections, reviewable instead of asserted.
03 · WORD OUTPUTThe impact analysis sits in your template
Impact rationales, document needs and proposed updates arrive as a Word file in the intended Change Control template — instead of being transferred repeatedly between assessment, risks and tests.
04 · HUMAN REVIEWEvery impact proposal carries its source
Source and rationale comments sit on the proposal itself. Your expert reviews relevance and test needs, corrects or rejects — formal approval remains in the responsible quality process.
05 · AUDIT TRAILThe decision stays traceable
Who assessed and decided which impact, and when, is in the audit trail — filterable and exportable when the auditor asks about this change.
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 change process — your quality process stays in the lead.
- Formal approval stays in your processtraqx prepares the impact assessment and the change draft. Decision and approval of the change remain in the leading quality process — traqx does not replace it.
- The handover is a Word fileThe Change Control draft arrives as a .docx in the familiar template — with visible changes and comments. It takes the same path as any manually written draft.
- Your team maintains sources in your own tenantYour team decides which SOPs, policies and system documents form the source space. EU-hosted; your documents are not used for model training.
DOCUMENT USE CASE · INCLUDED IN traqx
How does traqx support Change Control?
traqx connects the documented change with applicable SOPs, policies, system and process context and your Change Control template. It prepares the impact assessment, affected documents, risks, test needs and the change draft. Your team assesses the impact and decides; formal approval remains in the responsible quality process.
How does software support change control in GxP?
For planned changes that may affect product quality, reproducibility or the validated state, the current EU GMP Annex 15 calls for written change-control procedures within the pharmaceutical quality system. Potential impact is assessed using quality risk management; functions authorised under the PQS approve the change and, where appropriate, evaluate its effectiveness after implementation. Software should connect the request, impact assessment, affected systems, documents and tests, the decision, implementation and closure evidence. traqx prepares that chain from your released sources and shows, at every step, what is evidenced and what stays open. Your team reviews and decides.
FAQ
Frame Change Control with traqx clearly.
Is Change Control included in traqx?
Yes. Document-based Change Control work is a direct work case in traqx — from impact analysis to a reviewable change version.
Can traqx prepare an impact assessment?
Yes. Based on the change and controlled SOPs, policies, system and project documents, traqx prepares affected artefacts, rationales, gaps and the assessment draft.
Does traqx decide on the change?
No. The accountable expert assesses impact, risk and test needs. Formal decision and approval remain in the responsible quality process.
ONE PRODUCT · ONE REAL DOCUMENT
Evaluate it on your own change control 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