 GMP, GCP, GLP, QS and Part 11 / Systems Audits
21 CFR Part(s) 11, 210/211, 820, ICH Q7
Food and Supplement GMP Audits
Mock FDA - EMEA Audits
Pre-Site Inspections - 'For-Cause'
Quality Assurance Audits
Quality System Audits - Part 820
SOPs, Quality Assurance and Standards Audits
GMP - Good Manufacturing Practice Audit
GCP - Clinical Audits - Regulatory Audits
Equipment Validation Documentation Audit
Software / Systems Validation Audits
Part 11 / Annex 11 Compliance
Vendor & Supplier Audits -
CMOs, Laboratories, API Manufacturers
CROs, Investigators, Monitors, and Study Sites
Database Audits, SAS, CMMS, eDC, eCFR, Safety |
Project Management and Support Services
Gantt and Timeline Development
Validation Development and Executions
Training Services
Template Implementation
Procedures and Practice
Challenges
Standard Operating Procedures Development
Development Part 11 Initiatives
Design / Build Engineering Services
Certified AIA 'As-Built'
Drafting Services
Process and Equipment
Validation Services
Software and Systems Validation
Services
Design / Build Engineering Services
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