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Quality Support
examples
  • Implementation of Good Laboratory Practice (GLP)
    • Good Laboratory Practice training
    • Gap analysis & Implementation plan
    • Standard Operating Procedures (SOPs)
    • Work Instructions (WI)
  • Facility, process & study inspections
    • Preparation of Audit agenda, checklist, report
    • Visit on site, Interviews, Document review, Closing meeting
    • Corrective Action / Preventive Action (CAPA)
  • Quality Assurance (QA)
    • QA inspection of study plan, study phases & report
    • QA audits of external sites, vendor evaluation
    • QA support in validation …
Quality Support
process
  • Test facility/ Site
  • Quality program
  • Study preparation
  • Study plan
  • Verify study plan, amendments
  • Study results
  • Study report