FDA Quality Consulting – Systems and Training
“We’re just not where we should be with our systems, or our product & process knowledge to ensure product quality for the future.”
“We have reorganized and acquired companies without updating our systems — and now no one is sure what system to follow.”
“Our external suppliers are making changes without telling us.”
Compliance Architects® provides the following expert advisory and consulting services:
Quality System & Compliance Turnarounds / Restructuring
- Quality System Redevelopment
- Review / rewrite Quality Manual
- Review / rewrite Policies & SOPs
- Review / rewrite batch records, DMRs, etc.
- Review / redevelop CAPA, Training, Change Control, Validation, Management Review, etc. systems
- Metrics Development
- Governance Models
- Executive Issue Tracking & Accountability
Training / Coaching
- Custom GxP Training Programs
- Compliance Coaching
- Inspection Preparation Training
- Supplier Management Training
- Quality Staff Assessment / Development Programs
Quality & Compliance Computer-Based Systems
- Document management
- Knowledge management
- ERP Integration / Planning
- IT/IS Strategic Plans
- Regulatory submissions / SPL / XML
External Supply Chain Compliance
- Vendor selection criteria development & vendor qualification
- Quality agreement development
- Supplier management training
- Third party product / service monitoring / auditing
- Assessment metrics
- IS / IT solutions for supplier monitoring
Part 11 & Computer Systems Validation
- Part 11 advice / interpretations / compliance implementations
- Part 11 IS Quality Systems
- CSV Program Structure
Turnkey Quality Systems
- Quality systems development
- Develop & implement Quality Manual
- Develop & implement Policies & SOPs
- Develop & implement batch records, DMRs, etc.
- Develop & implement CAPA, Training, Change Control, Validation, Management Review, etc. systems
- Develop & implement governance programs, metrics, etc.
- Computer systems assessment / recommendations
- Quality “Software as a Service”
- Outsourced compliance staff