QAI operates as the entire QAU for a number of companies, conducting all duties required by the GLPs:

  • Maintain a copy of the master schedule
  • Maintain copies of all study protocols for GLP studies
  • Conduct GLP training of current and new study personnel
  • Conduct internal facility inspections
  • Conduct prequalification and requalification audits of CROs
  • Review all protocols before study initiation
  • Conduct inspections of all studies during one or more phases
  • Audit study data and study reports
  • Report all findings from audits and inspections to the study director and management
  • Prepare periodic reports to study directors and management
  • Sign the QA statement in the final report
  • Maintain a QA study file for each study
  • Maintain QAU SOPs
  • Assist client during Regulatoryinspection

QAI offers these services to the following company types:

  • Companies that prefer to outsource the QAU function
  • Facilities too small or too new to justify a full-time QAU
  • Industry Task Forces that require an outside independent QAU
  • University laboratories that prefer to outsource the QAU function

Case Study