Automated Visual Inspection (AVI) System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: Automated Visual Inspection (AVI) System

Subcategory: NDDS – NDDS Packaging & Integrity

Area: Production

DQ/IQ/OQ/PQ Flags:

  • Design Qualification (DQ): Yes
  • Installation Qualification (IQ): Yes
  • Operational Qualification (OQ): Yes
  • Performance Qualification (PQ): Yes

Acceptance Criteria Reference:

URS Annex11

Key Critical Parameters:

  • Detection Sensitivity
  • Reject Logic
  • Audit Trail

Requalification Frequency:

12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Automated Visual Inspection (AVI) System used in NDDS Packaging & Integrity. The report provides a comprehensive overview of the validation process, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope/Boundaries

The scope of this validation encompasses the AVI system’s functionality within the production area, focusing on its ability to meet specified acceptance criteria as per URS Annex11. The boundaries include all relevant equipment, software, and operational processes associated with the AVI system.

Executed Protocol List

  • DQ Protocol: AVI-DQ-001
  • IQ Protocol: AVI-IQ-001
  • OQ Protocol: AVI-OQ-001
  • PQ Protocol: AVI-PQ-001

Deviations Summary

No deviations were recorded during the validation process. All executed protocols complied with the predefined acceptance criteria.

CPP Verification Summary

All critical process parameters (CPPs) were verified during the validation process. The detection sensitivity, reject logic, and audit trail functionalities were tested and met the acceptance criteria as outlined in the URS.

Conclusion

The validation activities for the Automated Visual Inspection (AVI) System have been successfully completed. The system has been demonstrated to meet all acceptance criteria and is deemed suitable for use in NDDS Packaging & Integrity within the production area.

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Attachments Index

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

Approvals

Prepared by: [Name]

Approved by: [Name]

Date of Approval: [Date]

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