Quality Assurance — QMS
Deviation, change, CAPA, complaint, audit and training in one system
Quality assurance is where a regulator looks to see whether the plant learns from its own problems. Every element of the quality system is linked here — a deviation can raise a CAPA, a CAPA can drive a change control, a change control can trigger retraining — and the whole chain is visible in one review.
What Quality Assurance — QMS covers
Events
- Incident and deviation with classification, investigation and impact assessment
- OOS, OOT and CAPA with effectiveness checks that must close before the record does
- Market complaint handling through to investigation and customer response
- Recall and mock recall execution using batch genealogy
Control
- Change control with impact assessment, approvals and effective date
- SOP management with versioning, periodic review and read-and-understood records
- Training management linked to SOP versions and to role qualification
- Vendor audit and approved vendor list maintenance
Oversight
- Internal and external audit management with findings and closure tracking
- Risk management with assessment, mitigation and residual risk
- APQR with data pulled from production, QC and complaints
- Trend analysis across batches, materials and products
What the system notices for you
Suggestions only. Nothing here signs, approves or dispositions anything — a qualified person decides and the audit trail records who. Every model shows the data behind its suggestion, and every feature can be switched off per site.
Deviation clustering
Groups deviations by underlying cause rather than by category, so a repeat problem is visible before the annual review finds it.
CAPA effectiveness prediction
Compares a proposed action against what has actually worked for similar events in your own history.
APQR narrative drafting
Assembles the first draft of the review from the year's data, leaving the interpretation to your QA head.
Complaint-to-batch correlation
Links incoming complaints to batch, line, shift and material lot to find the pattern early.
Quality Assurance — QMS — common questions
Can a deviation be raised from the batch record?
Yes, inline from the failed step. The deviation carries the step context — product, batch, stage, equipment, operator, parameter and limit — so the investigator starts with the facts already attached.
How is APQR produced?
Data is pulled from production, QC, deviations, complaints and change control across the review period. The AI drafts a narrative from that data, and your QA head edits and approves it. The system never signs the review.
Works with
Every module shares one database, so nothing below is an integration — it is the same record seen from a different desk.
Costing
What the batch actually cost, not what the standard said
Read more EQEquipment Maintenance
Calibration status that actually stops the batch
Read more SDSales & Distribution
Order to dispatch, with batch and expiry all the way through
Read more EXExport Documentation
The document set, generated from the shipment rather than retyped for it
Read moreSee it on your own floor.
Two hours with your production and QA leads. We walk one product end to end and show you where it lands in the system — then you decide whether a gap study is worth it.