Services

Quality Assurance

Ce3’s Quality Director is actively involved in the GCP community, presenting at annual global industry conferences, maintaining a position on the DIA GCP Core Committee, and actively participating in the Society of Quality Assurance.

Our Quality Assurance team performs annual Internal Quality Reviews (IQRs) ensuring staff compliance with our SOPs and regulations while providing opportunities for continuous improvement. They oversee our comprehensive Quality Management System (QMS) which serves as a hub for our Standard Operating Procedures (SOPs), staff training and credential documentation, and Corrective and Preventative Action (CAPA) management system. In addition, our auditors conduct thorough qualification assessments to ensure that Ce3’s partners meet or surpass applicable regulatory requirements.

Services include:

  • Sponsor / CRO audits
  • CAPA and root cause analysis training
  • Investigator site audits
  • Trial Master File audits
  • CSR QC / audits
  • Vendor assessment and qualification
  • Customized GCP training
  • Inspection readiness
  • SOP writing / revision

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