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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