Quality Processes — Change Control, CAPA & QMS Linked to Regulatory Impact
Change Control That Knows Which Markets Must Approve
Change control, CAPA, deviations, audits, risk and controlled documents — every step signed, and every affected market’s filing tied to the regulatory record, so a change cannot close before the filings it needs.
Quality and regulatory track the same change in two places
A manufacturing change starts in Quality. Whether it can be implemented, and in which markets, is decided in Regulatory. In most companies those are two systems, joined by email, a spreadsheet and somebody’s memory.
The result is familiar to anyone who has been through an inspection: a change control closed as complete while a prior-approval supplement was still pending in one market, or a filing that nobody connected back to the change that triggered it.
DnXT Quality Processes puts the change and its regulatory consequences in one record. Each affected market carries its reporting category and its filing status, linked to the registration and the submission — and closure waits until the filings the change requires are in the state they need to be.
Built for the people who own the outcome
Quality managers
Run change control, CAPA, deviations and audits on signed routes that match your SOPs, with independence rules the system enforces rather than trusts.
Regulatory and CMC teams
See every change that affects a market you file in, with its reporting category, and record the submission and approval against it.
Manufacturing and site operations
Raise changes and deviations against the sites, products, materials, equipment and systems they affect, and see exactly what is needed to implement.
From proposal to verified closure
Raise and assess
Describe the change and its affected items. Each function’s impact assessment is assigned to a named assessor with a due date, and completed with a signature.
Approve on a signed route
The approval route for each change class is company configuration. Named people sign in order, and Quality signs last.
Implement and track markets
Actions have owners and evidence. Each affected market records its reporting category and status, linked to its registration and submission.
Close on evidence
Verification, residual risk and, where required, an effectiveness check. Closure is refused while a required filing is outstanding.
One quality system, connected to regulatory
Change control
Standard, major, minor and emergency changes. Emergency changes start immediately on a recorded verbal approval and are approved retrospectively within a set window.
CAPA
From problem statement to root cause, an approved plan, completed corrections and preventive actions, and an effectiveness judgement — with a follow-up CAPA when it was not effective.
Deviations, audits and findings
Deviations and audit findings follow the same signed workflow, with responses, due dates and owners visible in one place.
Risk register
Hazard, hazardous situation and harm in ISO 14971 terms. Risk levels are calculated, not typed, and Quality formally accepts the residual risk.
Controlled documents and training
SOPs, work instructions, policies and the Quality Manual with numbering, effective dates and periodic review. Training is assigned automatically when a document becomes effective.
KPIs and management review
Open, overdue and ageing records by type and owner, CAPA effectiveness and high risks — calculated live — and a signed management review record.
Design decisions that hold up in an inspection
Independence is enforced
The originator of a change cannot approve it, the implementer cannot approve its closure, and each role is filled by a named person from a maintained role register. The system refuses, rather than relying on people to notice.
A rejection starts a new cycle
When a change is returned, the approvals given before the rejection no longer count and must be given again. Earlier signatures stay in the history.
Signed content is frozen
What was approved cannot be edited afterwards. Closure fields lock once the first closing signature is applied.
Configurable without code
Approval routes, document review periods and training audiences are company settings, changed only by a Quality Manager with a signature — so the system fits your SOPs, not ours.
Frequently asked
Is Quality Processes 21 CFR Part 11 compliant?
Every signature records the signer’s printed name, the date and time, and the meaning of the signature. Any quality record can be produced as a PDF with its full signature manifest.
Can the approval routes match our SOPs?
Yes. The route for each change class is company configuration, changed only by a Quality Manager with an electronic signature. A change under approval keeps the route it was submitted with, even if the setting changes later.
How does it connect to regulatory submissions?
Each affected market on a change records its reporting category — none, annual report, notification or prior approval — and is linked to the registration and the submission. The filing state then decides whether the change can close.
Is it available now?
Quality Processes is in early access. Contact us to discuss joining the programme.
Close changes on evidence, not on memory.
Show us how a manufacturing change moves through your company today, and we will show you the same change in one connected record.
