Starting point
A food manufacturer had to become FDA-ready in a short time. The supplier qualification system had gaps, supplier documentation was incomplete and coordination with suppliers was unclear.
Without structured gap analysis and supplier qualification, inspection findings threaten the entire computer validation programme. Change control and an information platform had to run in parallel.
Approach
cube one assessed all relevant systems, qualified suppliers systematically and coordinated communication with internal and external stakeholders.
System evaluation and gap analysis
- Assessment of production and process control, LIMS, change control management and ERP.
- Gap analysis of the existing supplier qualification system.
- Critical review of supplier presentations and assessments.
Qualification and inspection preparation
- Supplier qualification planned and executed; full coordination with suppliers.
- Consulting to optimise the supplier management process.
- Targeted team preparation for authority inspection; accompanying change control.
- Built and maintained a structured information platform.
Tools: Veeva Vault Quality, TrackWise.
Result
FDA inspection
- Successfully passed FDA inspection.
- All suppliers with complete, reviewed documentation.
- Lean, audit-ready supplier management for future inspections.
Project operations
- Qualified partners with demonstrated suitability integrated.
- No information loss, clear responsibilities.
- Shorter response times and significantly fewer queries.
Related: DI gap assessment.