“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.”
- 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