Ensuring compliance with all regulatory requirements is at the heart of our operations at Q1 Scientific. Our QMS includes rigorous procedures and controls to ensure compliance with all regulatory requirements. We conduct regular internal audits and continuous training to keep our team updated on the latest standards and practices.
A robust Quality Management System
Our electronic Quality Management System (eQMS) is fully compliant with 21 CFR Part 11, EU Annex 11, and supports ISO 9001, 13485, 14791, and 27001. We have completed full system validation checks for compliance. Our comprehensive QMS controls and manages every aspect of our sample storage and management services, including:
- Document Management: Ensuring all documents are controlled, accessible, and up-to-date.
- Training: Continuous training programs to keep our team informed of the latest standards and practices.
- Change Control: Managing changes to processes and systems to maintain compliance.
- Deviations and Quality Events: Systematic handling of deviations and quality events to ensure corrective actions are implemented.
- CAPA Management: Comprehensive Corrective and Preventive Actions to address and prevent issues.
- Risk Assessments: Proactive identification and mitigation of risks.
- Customer Complaints: Efficient resolution of customer complaints to maintain high satisfaction levels.
- Audit Management: Regular internal and external audits to ensure ongoing compliance.
- Supplier Management: Ensuring suppliers meet our stringent quality standards.
Managing regulatory risk, compliance, and certification are critically important objectives for our Quality team.
