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Quality and QMS

Clinical365 maintain strict adherence to the highest quality standards, ensuring that your studies run smoothly.                                       

Our team stays up-to-date with the latest regulations, guaranteeing the highest level of quality and safety for your studies

Quality Management System

  • Extensive Quality Management System in place

  • Quality Management Software System – isoTracker

  • Detailed Standard Operating Procedures

  • Comply with all applicable regulatory and trade compliance requirements

  • Robust change control and risk management processes

  • Rigorous vendor qualification and management program in place

  • Well defined partner relationships in place governed by MSA’s

  • Continuous quality improvement processes

Scientist on Tablet

Quality Management System

  • Meets standards for ISO 9001 and 13485

  • Document Control

  • Complaints management

  • CAPA - Manage corrective and preventive action

  • Risk Management

  • Training Management

  • Non-conformance management

  • Equipment Management 

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