Quality Assurance

Quality Assurance

LSK Global PS performs independent audits and internal quality management in compliance with the ICH-GCP. LSK Global PS provides audits based on the ICH-GCP and consulting service built on the experiences in the audits of a lot of domestic/foreign pharmaceutical companies and CROs, and the inspections by the regulatory authorities. In addition, LSK Global PS is providing services for the development of standard operating procedures(SOPs) complying with the ICH-GCP and domestic laws/regulations, consultation, and vendor assessment. LSK auditors are composed of the experts qualified as the RQAP-GCP(Registered Quality Assurance Professionals in Good Clinical Practice)

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

50403020100 Phase I Phase II Phase III Phase IV Medical Device Bridging Study Others

Therapeutic Area

Oncology Cardiovascular Neurology Endocrinology Vaccine Medical Genetics Rheumatology Orthopedics Hepatology Infectious Disease Others 103 Projects (Updated on 2019.12.31)