Change Control · GAMP 5 / Annex 11 In development
See the change impact before it goes through.
Systems, SOPs, tests and documents are linked to the change before the validated state goes blurry.
Relevant to GAMP 5, EU-GMP Annex 11 and 21 CFR Part 11.
- Assess impact first, then approve.
- Deltas instead of scattered lists.
- Approval with rationale and evidence.
Change control lifecycleAnnex 15 §11 · ICH Q9(R1)
Change captured and locked · planned, in preparation
Why Change Control risks the validated state
A change is quickly requested. Its effect is not.
A change rarely touches only one thing. It runs through systems, SOPs, test cases, specifications and their evidence. If the impact only becomes visible after implementation, the validated state is already blurry — and the proof that it is not is missing.
01
The impact is underestimated
Which systems, documents and tests does this change really touch? If the impact assessment is filled from memory, an affected artefact too often stays undiscovered — until it shows up in the audit.
02
References fall apart across spreadsheets and emails
What connects to what lives in people's heads, spreadsheets and email threads. Every link between change, artefact and evidence is searched by hand — late, laborious and error-prone.
03
The evidence arises afterwards
That the assessment was complete, the approvals were in place and the deltas were implemented is pieced together after the fact. Exactly this gap between decision and evidence is a finding in the making.
How traqx should map your Change Control
Assess impact first — then let it go through.
The planned workflow builds on your change SOPs, templates and source spaces: Policy → SOP → Template. traqx should pre-structure assessments, make references visible and keep decisions traceable — you assess and approve. Generate · Verify · Monitor. The steps below describe the planned discipline, not a live feature.
Why this should hold up in the audit
The AI pre-assesses. You stay accountable.
When planned too, the traqx core principle applies: AI output is never silently written into a validated record. Until your approval, every impact assessment stays a proposal — and only your confirmation makes a change effective.
By construction
What a Change Control workflow should structurally secure.
Impact
before implementation
Effects on systems, SOPs, tests and documents become visible before the change goes through operationally — not afterwards in the audit. This keeps the validated state sharp instead of blurry.
1 → N
link
One change, linked through to every affected artefact and its evidence — the references arise along the way, instead of being pieced together afterwards from spreadsheets and emails. Gaps become visible earlier.
0
silent AI writes
No assessment and no delta lands in the record without human approval. By construction — not by discipline. This way you go into QA review and inspection better prepared.
Change Control is in preparation — not yet available; the value and workflow above are planned, not a live feature. The structural properties describe the intended construction — no guarantee of an audit outcome, but better preparation. We publish real time or cost effects only with reliable pilot or case-study data.
Questions from practice
Common questions on change control
What is change control in GxP?
The controlled process of assessing, approving, implementing and evidencing changes to systems, processes, equipment or documents. The goal: no change alters the validated or qualified state unnoticed.
Which changes require change control?
All changes with potential GxP impact: to validated systems, qualified equipment, critical processes, controlled documents or suppliers. Classification is risk-based — what counts is an evidenced impact assessment, not the size of the change.
What belongs in a change request?
Description and justification of the change, impact and risk assessment, affected systems and documents, planned actions including requalification or revalidation, approvals and the final effectiveness check.
How does AI help with impact assessment?
It finds affected documents, systems and dependencies across the whole inventory and drafts the assessment with source binding — precisely the cross-connections that manual reviews miss most often. Your team decides and approves.
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 this use case with us.
Change Control is in preparation — and early partners help determine the maturity level. Bring in a real change process that protects your validated state; we build the workflow on your reality, instead of claiming a finished product. We define scope and goals together before the start.
No sales pitch — a short conversation around your concrete Change Control scope. Change Control stays clearly marked as a roadmap use case; the documented assessment is yours even if you say no afterwards. EU-hosted, no model training, source room deleted on request with evidence.