- Individual external GxP and/or client specification audit evaluations in various regions such as:
- Asia (including China)
- Europe
- US (including Puerto Rico)
- Internal audits and gap analyses
- vs. regulatory standards and/or unique client procedures
- Complete audit program tracking and management services
- Competing regulation analysis and integration (e.g. ISO17025 with US GMP/21CFR211; ISO13485 with US QSR/21CFR820; etc.)
- Supplier Quality Agreements
- Sponsor vs. Contractor expectation/deliverable analysis
- Compliance Enhancement Programs for drugs, biologics, devices, and combination products
- CAPA system development
- CAPA tracking program management
- Corporate Compliance Master Plans
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