The system
Four modules live, four in build
MasetraQMS is the first platform in the Masetra Systems ecosystem. Deviation, CAPA, risk and change management are working today and share one record — a deviation raises a CAPA, the CAPA carries a risk assessment, and the change that follows is linked to both.
Where we are
We list what is built and what is not, in that order, on the page where you decide whether to buy. Document, training, vendor and audit management are in build for phase two and are included in the pro plan as they ship.
Module 01
Deviation Management
Deviations are logged where they happen, classified by risk, investigated against a defined process, and closed with evidence — instead of living in a notebook until audit week.
What it includes
- Structured capture with immediate notification
- Risk classification and impact assessment
- Investigation workflow with defined owners and due dates
- Linkage to affected batches, equipment and processes
- Escalation to CAPA where the root cause warrants it
Module 02
CAPA Management
Root cause analysis, action plans with owners and dates, and a verification step that proves the fix worked — the part most CAPA systems quietly skip.
Target: no CAPA closed without a recorded effectiveness check.What it includes
- Structured root cause analysis
- Corrective and preventive action plans with accountable owners
- Effectiveness verification before closure
- Trending across recurring causes
- Complete history for inspection
Module 03
Risk Management
A live risk register rather than an assessment done once and filed. Risks are rated consistently, controls are recorded against them, and the reasoning behind a decision survives the person who made it.
What it includes
- Risk registers with consistent rating criteria
- Assessment linked to the deviation or change that raised it
- Controls and mitigations recorded against each risk
- Residual risk tracked after mitigation
- Periodic review so ratings do not go stale
Module 04
Change Management
Proposed changes are risk-assessed, routed to the right approvers, and tracked through implementation — with the actions that follow linked rather than remembered.
What it includes
- Change request capture with impact assessment
- Multi-level approval by change classification
- Risk assessment built into the change record
- Implementation tracking to closure
- Post-implementation review
Phase two
In build, not yet available
Four more modules are being written now. They complete the chain — a document revision triggering retraining is the step that closes the loop — and they arrive inside your existing plan.
Coming soon
Document Management
Versioned procedures with controlled approval and electronic signatures.
Coming soon
Training Management
Know who is qualified to do what, and prove it.
Coming soon
Vendor Management
Qualify vendors once, then monitor them continuously.
Coming soon
Audit Management
Plan internal audits, track findings, and stay inspection-ready.
Try it on your own deviations
The free trial runs for a month with all four live modules and five users. Bring a real deviation from last quarter and follow it through to a closed CAPA — that will tell you more than any demo we could give.