Quality Management Service
SERVICE ▶
Quality Management Service
- Risk-Based Quality Management System (RQMS)
- GCP audit service
- GLP and GCLP audit service
- GVP audit service
- Mock Inspection
- QMS consultation
- Training
Risk-based quality management is a systematic process to identify, assess, control, and review risks throughout clinical trial planning, conduct, and reporting.
QVIS provides risk-based quality management services through SOP development and management, training, audits, CAPA management, and management of non-compliance and deviations.
QVIS provides risk-based quality management services through SOP development and management, training, audits, CAPA management, and management of non-compliance and deviations.
· Annual quality management planning based on risk analysis
· Quality management activities according to the annual plan
· Follow-up actions for issues, non-compliance, and deviations identified during QA activities
· Reflecting improvements in the next annual QA plan based on completed QA results
· Quality management activities according to the annual plan
· Follow-up actions for issues, non-compliance, and deviations identified during QA activities
· Reflecting improvements in the next annual QA plan based on completed QA results
Independent GCP audits are essential procedures to confirm and improve clinical trial quality.
QVIS verifies compliance with applicable regulations, SOPs, and protocols, identifies risks, and proposes improvement measures.
QVIS verifies compliance with applicable regulations, SOPs, and protocols, identifies risks, and proposes improvement measures.
QVIS provides GLP and GCLP audit services by reviewing facilities, SOPs, analytical method validation, analytical reports, and training status.
QVIS helps clients verify and optimize their pharmacovigilance systems in line with regulatory requirements.
· Audit pre- and post-marketing pharmacovigilance procedures for compliance with regulations, SOPs, and Safety Data Exchange Agreements (SDEA)
· Audit pharmacovigilance procedures of pharmaceutical companies, affiliates, marketing partners, and distributors
· Review pharmacovigilance-related documents
· Assess adequacy of pharmacovigilance training
· Audit pharmacovigilance procedures of pharmaceutical companies, affiliates, marketing partners, and distributors
· Review pharmacovigilance-related documents
· Assess adequacy of pharmacovigilance training
Based on extensive inspection experience including FDA, PMDA, and MFDS, QVIS supports preparation for and response to inspections.
· Source document review and essential document review for selected subjects
· Inspection-related training including interviews and role play
· Advice on coordination and management of inspection-related matters
· Support for efficient and successful inspection conduct
· Identification and prioritization of improvement items
· Corrective action support
· Site readiness support for inspections
· Inspection-related training including interviews and role play
· Advice on coordination and management of inspection-related matters
· Support for efficient and successful inspection conduct
· Identification and prioritization of improvement items
· Corrective action support
· Site readiness support for inspections
QVIS provides services to help establish clients' quality management systems.
· Overall quality assurance function support for client organizations
· Assessment of clinical trial quality assurance systems
· Compliance assessment for clinical development teams
· Advice on quality and efficiency improvement
· Assessment of clinical trial quality assurance systems
· Compliance assessment for clinical development teams
· Advice on quality and efficiency improvement
QVIS provides customized training to meet client requirements.
· Good Clinical Practice
· Good (Clinical) Laboratory Practice
· Good Pharmacovigilance Practice
· Clinical trial quality assurance
· Korean and U.S. clinical trial regulations
· Site inspection preparation
· Auditor training
· CRO Management
· Project Management
· Quality by Design
· Good (Clinical) Laboratory Practice
· Good Pharmacovigilance Practice
· Clinical trial quality assurance
· Korean and U.S. clinical trial regulations
· Site inspection preparation
· Auditor training
· CRO Management
· Project Management
· Quality by Design