At ARIREX, we understand that a robust Quality Management System (QMS) is the backbone of any compliance strategy. We help organizations design, implement, and optimize QMS frameworks that are not only compliant with regulations like ISO 13485, 21 CFR Part 820, and ICH Q10 but are also efficient and scalable.
Our approach focuses on simplifying complex quality processes to ensure they are practical and easy to follow. From developing Standard Operating Procedures (SOPs) to managing deviations and Corrective and Preventive Actions (CAPAs), we provide end-to-end support for your quality function.
QMS Solutions
We offer customized solutions to address the specific quality challenges faced by your organization, ensuring a culture of quality and continuous improvement.
- QMS Design & Implementation.
- Standard Operating Procedure (SOP) Development.
- CAPA, Deviation, and Non-Conformance Management.
- Change Control System Optimization.
- QMS Remediation and Gap Assessment.
Benefits of a Strong QMS
An effective QMS does more than just satisfy auditors; it drives business performance and product reliability.
- Robust Compliance: Establish a solid framework that withstands regulatory scrutiny.
- Operational Efficiency: Streamline processes to reduce waste and error rates.
- Data-Driven Decisions: Utilize quality metrics to identify trends and improve performance.