Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities conducted for the Vision System utilized in the packaging and inspection of IV Infusions (LVP/SVP – Bags/Bottles). The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, as well as acceptance criteria, critical parameters, and approvals.

Scope/Boundaries

The scope of this validation covers the Vision System used for code and label verification in the packaging area for IV Infusions. The boundaries include all operational aspects of the Vision System, including setup, calibration, and routine operation within the specified environment.

Executed Protocol List

• Design Qualification (DQ) Protocol: DQ-001
• Installation Qualification (IQ) Protocol: IQ-001
• Operational Qualification (OQ) Protocol: OQ-001
• Performance Qualification (PQ) Protocol: PQ-001

Deviations Summary

No deviations were reported during the validation process. All activities were completed in accordance with established protocols and acceptance criteria.

CPP Verification Summary

The key critical parameters for the Vision System include:

• Read Rate: Confirmed to meet the acceptance criteria of 99% or greater.
• Reject Logic: Functionality verified to ensure proper rejection of non-conforming products.
• Audit Trail: Confirmed to maintain a complete and accurate record of system operations.

Conclusion

The validation of the Vision System for IV Infusions (LVP/SVP – Bags/Bottles) has been successfully completed. All phases of validation (DQ, IQ, OQ, PQ) were executed, and acceptance criteria were met. The system is deemed compliant and suitable for its intended use.

Attachments Index

• Attachment 1: DQ Protocol Report
• Attachment 2: IQ Protocol Report
• Attachment 3: OQ Protocol Report
• Attachment 4: PQ Protocol Report
• Attachment 5: Validation Summary Report

Approvals

Prepared by: [Prepared By Name]
Date: [Date]
Approved by: [Approved By Name]
Date: [Date]