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Quality Management

Our team approach to quality management begins in the implementation phase and exists within all systems and processes throughout the lifecycle of a program or clinical trial.  The approach includes the incorporation of standardization through education, written procedures, the establishment of defined metrics, and auditing.

We offer the following Quality Management Services:
  • Quality Management Plans
  • Metrics for Performance and Compliance
  • Independent Data Auditing
  • 21 CFR Part 11 Compliance
  • GLP, GMP, and GCP Consultation, Training, and Auditing
  • Standard Operating Procedures
  • Regulatory Master File Review
  • Preparation and Facilitation of Third Party Audits
  • Site GPC Audits
  • Vendor Qualification Audits
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