Royal Quality Pillars
Quality Managament System QMS
Empower your quality operations with a secure, compliant, and integrated platform designed for regulated industries.
Key Features
Change Control
- Centralized change request initiation with unique ID
- Impact assessment (product, regulatory, validation, etc.)
- Risk-based categorization of changes (minor, major, critical)
- Workflow-driven approval process with role-based access
- Linkage to related deviations, CAPAs, and documents
- Implementation plan with milestones and deadlines
- Automated reminders and escalations
- Change implementation effectiveness review
- Full audit trail and change history
- Reporting on open, closed, overdue changes
CAPA Management (Corrective and Preventive Actions)
- CAPA initiation from deviations, audits, complaints, etc.
- Root Cause Analysis tools (5-Why, Ishikawa/Fishbone)
- Risk-based CAPA prioritization
- Assign responsibilities, due dates, and resources
- Real-time CAPA implementation tracking
- Verification of Effectiveness (VoE) and closure workflow
- Audit trails and electronic signature compliance
- CAPA aging and overdue alerting
- Trend analysis and effectiveness KPIs
Deviation & Incident Management
- Categorization (planned/unplanned, criticality level)
- Initial assessment and immediate containment
- Root cause analysis and investigation tools
- Workflow-based approvals and escalation
- Automatic generation of linked CAPA or change request
- Deviations trending and recurring issue detection
- Integration with batch records and audit trails
- Dashboards for deviation rates by area/product/line
- User-friendly interface for QC, production, QA teams
Audit Management
- Annual audit planning and scheduling
- Creation of audit checklists and audit execution tracking
- Management of audit findings and observations
- Generation of CAPAs for audit gaps
- Assignments, deadlines, and follow-up notifications
- Auditor and auditee role definitions
- Risk-based audit scoring and trending
- Audit closure and reporting (internal, external, supplier)
- Historical audit repository for regulatory inspections
Risk Management
- Risk assessment templates (FMEA, Risk Matrix)
- Severity, occurrence, and detectability scoring
- Automated risk prioritization (RPN calculation)
- Link risks to CAPAs, change controls, deviations, etc.
- Risk mitigation planning and tracking
- Re-assessment post-change or event
- Risk register with history and trending
- Supports ICH Q9(R1) and ISO 14971 principles
Complaints & Recall Management
- Complaint intake form with product/batch tagging
- Classification of complaint (quality, efficacy, safety)
- Investigation workflows and root cause tracking
- Generation of CAPAs and change controls where applicable
- Recall initiation, tracking, and closure workflows
- Regulatory reporting (FDA MedWatch, EMA forms, etc.)
- Complaint trending by product, region, root cause
- Customer feedback documentation and audit readiness