The Service Provider shall perform independent oversight activities and shall not perform or assume responsibility for supplier manufacturing or product release decisions.

2.1 Supplier Oversight & Governance
- Act as an independent quality oversight body, separate from supplier operations
- Monitor supplier:
- Product testing execution
- Deviations, nonconformances, and CAPAs
- Quality system effectiveness
- Participate in governance forums and provide objective reporting directly to Company
- Maintain documented independence from supplier influence

2.2 Product Testing Oversight
- Verify supplier adherence to:
- Validated test methods
- Approved specifications
- Confirm:
- Test methods are approved by Company prior to implementation
- Equipment remains in validated state (IQ/OQ/PQ)
- Laboratory controls meet regulatory requirements

2.3 Data Integrity & Verification
- Perform independent verification of:
- Raw data vs reported results
- Test records and documentation
- Ensure compliance with ALCOA principles
- Provide input to Minimed to conduct Trend analysis,



Anomaly detection

2.4 Batch Oversight (Post-Release)
- Conduct independent post-release review of batch documentation
- Review:
- Certificates of Analysis (COA)
- Supporting data sets
- Provide risk-based recommendations to Company regarding:
- Product acceptance
- Potential distribution risks

2.5 Escalation & Risk Management
- Identify and escalate to company risk conditions including:
- OOS/OOT results
- Data integrity concerns
- Repeated deviation trends
- Escalations shall be made directly to Company without supplier mediation
- Recommend containment actions including Shipment holds

2.6 Sampling & Statistical Oversight
- Verify supplier sampling plans align with: ISO 2859-1 / ANSI Z1.4 standards as applicable
- Evaluate effectiveness of: Normal / Tightened / Reduced inspection levels if utilized by supplier
- Provide independent recommendations regarding sampling adequacy

2.7 Performance Monitoring

📌 Independent Supplier Quality (Reynosa)
🏢 LanceSoft
📍 Reynosa