Building Robust, Traceable & Inspection Ready Quality Systems
ARIREX specializes in designing, optimizing, and remediating Quality Management Systems (QMS) for pharmaceuticals, biologics, food and beverage, cosmetics, natural health products, medical devices, drug product distribution, and other regulated industries. Our QMS solutions are built to meet global regulatory expectations while remaining practical, scalable, and aligned with real-world operations.
We help organizations establish strong quality foundations that support compliance, operational efficiency, data integrity, and long-term sustainability. Whether you are building a new system, upgrading an existing one, or preparing for regulatory inspections, ARIREX ensures your QMS is structured, defensible, and inspection-ready.
Our QMS Expertise
QMS Design & Implementation
We develop complete, end-to-end quality systems aligned with:
- GMP, GDP, GLP, GCP
- ICH Q9/Q10
- ISO 9001, ISO 13485, ISO/IEC 17025
- FDA and Health Canada expectations
Our systems are built to be clear, traceable, and easy for teams to follow.
QMS Remediation & Optimization
For organizations facing compliance gaps, audit findings, or operational inefficiencies, ARIREX provides:
- Gap assessments and remediation plans
- SOP harmonization and documentation cleanup
- Streamlined workflows and risk-based improvements
- Governance and quality oversight frameworks
Documentation Lifecycle Management
We create and refine documentation systems that support:
- SOP development and harmonization
- Controlled document workflows
- Version control and change management
- Training and competency linkage
Deviation, CAPA & Change Control Systems
We design structured, evidence-based systems for:
- Deviation management
- Root cause analysis
- CAPA effectiveness
- Change control governance
- Trending and continuous improvement
Risk Management Frameworks
We implement risk-based approaches aligned with ICH Q9, ISO 14971, and global expectations, ensuring decisions are defensible and traceable.
Quality Governance & Management Review
We help organizations establish:
- Quality metrics and KPIs
- Management review processes
- Internal quality committees
- Continuous improvement programs
Industry Specific QMS Support
Pharmaceuticals & Biologics
- GMP aligned QMS development
- Validation lifecycle integration
- Data integrity frameworks
- Batch documentation and release systems
Food & Beverage
- HACCP and preventive control programs
- Allergen, sanitation, and traceability systems
- Supplier and ingredient qualification
Cosmetics & Personal Care
- ISO 22716 aligned QMS
- Claims, labeling, and ingredient compliance
- Market readiness for Canada, USA, and EU
Medical Devices
- ISO 13485 QMS development
- Technical documentation and risk management
- Supplier and manufacturing controls
Drug Product Distribution
- GDP aligned quality systems
- Licensing and compliance documentation
- Environmental monitoring and transportation controls
Our Approach
- Regulatory Aligned: Built to meet or exceed expectations from FDA, Health Canada, EMA, EU GMP, ICH, and ISO standards.
- Operationally Practical: Systems that integrate smoothly into existing workflows without adding unnecessary complexity.
- Evidence Driven: Every requirement is supported by global guidelines and industry best practices.
- Clear & Traceable: Documentation and processes designed to withstand audits and regulatory scrutiny.
- Scalable & Sustainable: QMS frameworks that grow with your organization and support long-term compliance.
Why Organizations Trust ARIREX
- Deep expertise across regulated industries
- Strong understanding of real-world operational challenges
- Structured, audit-ready documentation
- Transparent, collaborative working style
- Long-term support for continuous improvement
ARIREX helps organizations build quality systems that not only meet regulatory requirements but strengthen operational excellence and long-term resilience.