Oasis-QMS (Quality Management System)
Deviations, CAPA, change control & audits — unified in one quality hub.
Change Control
Controlled Change Management Across Quality Systems
Change Initiation
Structured forms with category & urgency classification.
Risk Assessment
Quality risk matrix with impact-level scoring.
Approval Routing
Configurable multi-tier approval chains.
Action Items
Task assignment with ownership & due-date tracking.
Change Reports
Status dashboards and overdue change alerts.
CAPA & Deviation Link
Associate changes with related CAPAs and deviations.
Deviation Management
Planned & Unplanned Deviation Investigation Workflows
Deviation Reporting
Immediate capture with impact & severity scoring.
Root Cause Analysis
5-Why & fishbone tools built into the workflow.
Containment Actions
Immediate corrective steps with assignment.
CAPA Generation
One-click CAPA creation from any deviation record.
Trend Analysis
Recurring deviation patterns identified automatically.
Regulatory Reports
GMP-ready reports for site quality review.
CAPA
Corrective & Preventive Action Management
Source Tracking
CAPA linked to deviations, audits, complaints.
Action Plan
Step-by-step plan with individual task owners.
Approval Workflow
QA review and final approval with e-signature.
Effectiveness Review
Evidence-based verification after completion.
Escalation
Auto-escalation for overdue & high-risk CAPAs.
CAPA Dashboard
Status overview with ageing & closure metrics.
Risk Management
Identify, Assess, Mitigate — Manage Quality Risks with Confidence
Identify, Assess, Mitigate
Manage quality risks with confidence across processes, products, and systems.
End-to-End Coverage
Proactive quality assurance from risk registration through to formal closure.
Structured Workflow
From risk identification to mitigation on a single traceable path.
Visibility & Control
Risk-based quality management with complete oversight of every open risk.
Integrated into QMS
Proactive risk management running inside your existing QMS workflow.
Monitor Actions
Assess risks, drive mitigation, and monitor actions — all within one QMS.
Auditing Management
Plan, Execute & Track Internal and External Audits
Audit Planning
Annual schedule with type, scope & auditor.
Checklist Library
GMP, ISO, and custom checklist templates.
Finding Management
Critical / major / minor classification & evidence.
CAPA Linkage
Direct CAPA creation from each finding.
Audit History
Complete records for inspection readiness.
Trend Reports
Recurring findings across departments & periods.
Complaints Management
Structured Product Complaint & Market Feedback Handling
Complaint Intake
Web form or manual entry with product & batch link.
Sample Investigation
Lab retesting workflow triggered from complaint.
Investigation Assignment
Multi-department investigation with deadlines.
Customer Letters
Templated regulatory response letters.
Reportability Check
Flags serious complaints for regulatory reporting.
Complaint Trends
Product / batch / type pattern analysis.
Oasis APQR
Automated Annual Product Quality Review
Data Aggregation
Auto-pulls batches, QC, stability & complaint data.
Statistical Summary
Yield, OOS, CAPA, deviation counts per product.
Auto PDF
Formatted APQR report generated in one click.
Review Approval
QA/QP review with electronic signature.
Year-on-Year
Prior-year comparison for trend identification.
APQR Archive
Searchable repository of all historical reports.