Quality & Compliance
Quality Management Systems & SOPs
Quality management systems and SOPs for sponsors, sites, CROs and start-ups.
What's Included
- QMS design and implementation
- SOP writing, review and gap analysis (GCP, PV, DM, CSV, GMP)
- Work instructions, forms and templates
- Document control and records management
- Training programs and training matrices
- Quality risk management (ICH E6(R3), ICH Q9)
- Deviation and CAPA systems
- Quality metrics, KPIs and management review
- Vendor management programs