QSigma360

Integrated quality management product

Available

Make every quality event the start of a clear path to decision and improvement

QSigma360 Quality Management connects records, evidence, responsibilities, and decisions across coordinated modules. Your team can move from detection to investigation, action, verification, and reporting without losing context between systems or files.

Quality events moving through investigation, action, verification, and reporting in one connected context
One entry point for quality events
Investigation that preserves context
CAPA that can be followed and evaluated
Governed change instead of isolated fixes

Who is this product for?

For quality, compliance, and operations leaders; process owners; audit and supplier-quality teams; and multi-site organizations that need consistent event management, action follow-up, and reviewable evidence.

Move from record tracking to business outcomes

A quality issue is not resolved when it is logged. Value comes from preserving evidence, understanding causes, implementing actions, and checking whether the response worked. Spreadsheets, messages, and folders make accountability harder to see and recurrence harder to control.

QSigma360 Quality Management coordinates available quality modules around one operating outcome. Each record retains its lifecycle and permissions, while links among nonconformance, complaints, CAPA, audits, change, documents, and reports remain traceable. Teams gain a clearer view of open work, due dates, recurrence, and decision evidence.

Six outcomes supported by the product

1. One entry point for quality events

Capture complaints, nonconformances, audit findings, and deviations with classification, ownership, priority, and evidence.

2. Investigation that preserves context

Connect observations, attachments, investigation questions, and root-cause analysis to the originating event.

3. CAPA that can be followed and evaluated

Assign corrections and actions with owners, dates, and evidence, then document authorized effectiveness review before closure.

4. Governed change instead of isolated fixes

Relate significant changes to impact, risk, documents, and implementation actions with traceable human review.

5. Documents and reports connected to work

Open relevant controlled documents from record context and connect approved data to governed reporting outputs.

6. Explainable management visibility

Monitor open work, delays, trends, and recurrence, then inspect the records supporting each metric.

The operating journey

  1. 1Capture: Record the event, facts, and evidence from the appropriate source.
  2. 2Assess and route: Set type, severity, priority, owner, and review path.
  3. 3Investigate: Gather facts, analyze causes, and document conclusions.
  4. 4Act: Assign corrections, CAPA, or required change with clear due dates.
  5. 5Verify: Authorized people review implementation evidence and effectiveness.
  6. 6Learn and report: Analyze recurrence and trends to inform improvement decisions.

Integration and governance

The product connects Nonconformance and Complaints, CAPA, Audits, Change Control, Document Control, and Reports. Supplier and food-safety context is available when relevant modules are enabled. Roles and permissions govern work, and material events remain traceable. The AI Quality Copilot may suggest wording or review points; it cannot approve, sign, alter an official record, or close it automatically.

Journey from the governing content

How the product journey moves

Illustrative view with no customer data
  1. 1

    Capture: Record the event, facts, and evidence from the appropriate source.

  2. 2

    Assess and route: Set type, severity, priority, owner, and review path.

  3. 3

    Investigate: Gather facts, analyze causes, and document conclusions.

  4. 4

    Act: Assign corrections, CAPA, or required change with clear due dates.

  5. 5

    Verify: Authorized people review implementation evidence and effectiveness.

  6. 6

    Learn and report: Analyze recurrence and trends to inform improvement decisions.

Frequently asked questions

How is this product different from the Quality Management System module?

The product coordinates modules around an end-to-end outcome; a module provides a defined capability. Enabled scope depends on subscription and workspace configuration.

Can it support multiple sites or departments?

QSigma360 supports facilities, departments, roles, and workspace controls. Scope, access, and permissions reflect the organization’s approved structure.

Does the product guarantee quality certification?

No. It organizes processes, records, and evidence but does not award certification or guarantee compliance. Verification and assessment remain independent responsibilities.

Is the product available in Arabic and English?

Yes. QSigma360 supports right-to-left Arabic and left-to-right English interfaces within the applicable workspace permissions.

See how quality events become traceable decisions

See how QSigma360 connects investigation, action, effectiveness, and reporting around your processes.

Start with a tailored demo built around your organization’s needs.