Quality Excellence

Quality Management System (QMS)

Simplify audits and compliance by digitizing all quality processes. Manage CAPAs, deviations, change controls, and audits in one integrated platform with built-in continuous improvement workflows.

Dashboard CAPAs Audits Deviations

Open CAPAs

12

Audit Score

96%

On-Time Close

98.5%
CAPA-2024-089 Corrective In Progress 12 days
CAPA-2024-088 Preventive Closed -

Comprehensive Quality Management

All quality processes in one integrated system for complete visibility and control.

CAPA Management

End-to-end corrective and preventive action tracking. Root cause analysis tools and effectiveness verification.

Deviation Handling

Capture, investigate, and resolve deviations quickly. Classification, impact assessment, and trending analysis.

Audit Management

Plan, execute, and track internal and external audits. Finding management and follow-up workflows.

Change Control

Structured change management with impact assessment, approvals, and implementation tracking.

Complaint Management

Customer complaint intake, investigation, and resolution. Trend analysis and reporting.

Risk Management

Quality risk assessment and mitigation. Risk registers, FMEA support, and control monitoring.

Investigation

The Investigation component ensures that problems are not guessed, ignored, or temporarily fixed, but logically analyzed and permanently resolved.

Incident

Helps users capture unwanted events early, preventing hidden issues from affecting results and ensuring every decision is based on the right conditions.

OOT-OOC-OOS

Highlights when machine performance starts drifting from historical patterns, even if results look acceptable. Spot hidden shifts early and keep processes stable.

Drive Continuous Improvement

Transform quality from a compliance burden into a competitive advantage.

1

Pass Every Audit

2

45% Faster CAPA

3

Proactive Quality

4

Complete Visibility

Built for Regulated Industries

Pre-configured for major quality standards with the flexibility to adapt to your specific requirements.

ISO 9001:2015
ISO 13485
FDA 21 CFR Part 820
GMP/GLP Requirements
ICH Q10
EU MDR/IVDR

Plan

Define objectives, metrics, and quality goals

Do

Execute processes and capture data

Check

Monitor, measure, and analyze results

Act

Implement improvements continuously

Ready to Elevate Your Quality Management?

See how Fiscal Ox QMS can transform your quality processes. Schedule a personalized demo today.