“Our budgets have been cut and we can’t seem to get our CAPAs closed.”
“All of our investigations say Operator Error — somethings wrong with that.”
“Our processes have way too much scrap and failure — we need to be much more efficient and reduce our fixed costs!”
Compliance Architects® provides the following expert advisory and consulting services:
Product Quality Consulting
- Quality by Design (QbD) systems & approaches
- HACCP Quality Plans
- Operational Excellence
- Process Criticality Analysis
- FMEAs, CAPA Investigations, Investigation Training
Operational Efficiency / Compliance Effectiveness
- Operational Excellence programs
- “Compliance Aware” Process Excellence
- “Lean Compliance”
- Business process modeling & re-engineering
- Risk management plans
- Metrics and Governance Systems Development
Project / Program Management
- Compliance remediation project management
- Operational improvement projects
- Investigations project management
- Commercialization & regulatory submissions