SERVICES

Quality Assurance

Quality Assurance

ICH-GCP 기반의 독립적인 Audit과 Internal quality management를 수행합니다. 다수의 국내/해외 제약사 및 임상시험수탁기관(CRO)의 점검과 규제기관의 실태조사 경험을 토대로 ICH-GCP 기반 Audit과 Consulting 서비스를 제공합니다. 또한 ICH-GCP 및 국내 법/규정에 맞는 표준작업지침서(SOPs)의 개발 및 자문, 공급업체평가(Vendor Assessment) 서비스도 제공하고 있습니다. LSK Auditor는 RQAP-GCP(Registered Quality Assurance Professionals in Good Clinical Practice) 인증을 받은 전문가들로 구성되어 있습니다.

Brochure_Quality Assurance

Audit Process

Planning
  1. 01 Audit planning
  2. 02 Sending the audit introductory letter to auditees
Conducting
  1. 01 Document review
  2. 02 Interviews
  3. 03 Confirmation and evaluation of audit observations
Reporting
  1. 01 Issuing the audit report and audit certificate
Follow-up
  1. 01 Follow-up the corrective and preventive actions

Service Scope

Audit (Study specific, System)

Vendor / Sub-contractor assessment

SOP development and management

Audit CAPA management

Experience

Study Types

454035302520151050 Phase I Phase II Phase III Phase IV Medical Device Bridging Study Others

Therapeutic Area

Oncology Cardiovascular Neurology Endocrinology Medical Genetics Vaccine Rheumatology Orthopedics Infectious Disease Gastroenterology Others Hepatology Ophthalmology Respiratory 117 ProjectsAs of 2022.12.31