Hohe Kosten für Lieferantenaudits
Definition
Onsite audits and continuous monitoring create significant overhead in personnel time and travel for supplier qualification.
Key Findings
- Financial Impact: €5,000-€20,000 per onsite audit; 40 hours/supplier qualification cycle
- Frequency: Initial + annual requalification for critical suppliers
- Root Cause: Mandatory onsite audits for high-risk suppliers without remote alternatives
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
Supplier Qualification Coordinator, Auditor, Qualitätsbeauftragter
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
GMP-Auditversagen bei Lieferantenqualifizierung
Qualitätsmängel durch unqualifizierte Lieferanten
Produktionsausfälle durch Serialisierungs-Engpässe
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten der Abweichungsuntersuchung und CAPA
Bußgelder bei CAPA-Mängeln
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