Audit

Audit

GCP audit is an indispensable part for a GCP compliant trial focusing on providing independent examinations of clinical trial related activities to assure that the data and reported results are credible, accurate and integral, and that the rights and confidentiality of subjects are protected.

VCRO provides both external GCP audits and in-house quality assurance audits for all VCRO research processes and services. Quality Assurance Unit (QAU) serves as an independent group within VCRO to help our clients meeting the international ethical and scientific standards of GCP.

For all VCRO services, QAU supports initiating, developing, implementing, maintaining, analyzing, and reporting clinical trials based on VCRO quality management systems to ensure all services meeting the standards of contracted items, namely, relevant VCRO SOPs, ICH guidelines, US FDA 21 CFR Part 11, US FDA 21 CFR Part 58, US FDA 21 CFR Part 312, OECD GLP, TFDA GLP requirements and applicable country regulations.

  • Phase I - IV GCP audits
  • Site audits
  • Investigational product labeling and packaging process audits
  • VCRO clinical database audits
  • VCRO bioanalytical laboratory GLP audits
  • VCRO operational vendor audits
  • Internal system and process audits
  • Essential documents audits
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