Device Inspection System (Vision/Microscopy) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment

Device Inspection System (Vision/Microscopy)

Subcategory

NDDS – Drug-Eluting Stents / Coated Devices

Area

QC/R&D

DQ/IQ/OQ/PQ Flags

Yes / Yes / Yes / Yes

Acceptance Criteria Reference

URS Annex11

Key Critical Parameters

Detection accuracy, calibration data integrity

Requalification Frequency

12 Months

Summary

This Validation Summary Report provides an overview of the validation activities performed on the Device Inspection System utilized in the Quality Control and Research & Development areas for NDDS – Drug-Eluting Stents and Coated Devices. The report confirms adherence to established acceptance criteria and outlines the executed validation protocols.

Scope/Boundaries

The validation encompasses the Device Inspection System’s functionality and its application in the inspection of drug-eluting stents and coated devices within the QC/R&D area. The boundaries of this validation include all operational and system performance aspects as defined in the URS Annex11.

Executed Protocol List

  • DQ Protocol
  • IQ Protocol
  • OQ Protocol
  • PQ Protocol

Deviations Summary

No deviations were noted during the execution of the validation protocols. All activities were conducted in accordance with the established procedures and acceptance criteria.

CPP Verification Summary

All critical process parameters (CPPs) were verified during OQ and PQ phases. Detection accuracy was confirmed to meet the acceptance criteria, and calibration data integrity was maintained throughout the validation process.

Conclusion

The Device Inspection System has successfully passed all validation phases (DQ, IQ, OQ, PQ) and is deemed suitable for its intended use in the inspection of NDDS – Drug-Eluting Stents and Coated Devices. The system is compliant with URS Annex11, and all key critical parameters have been verified.

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Attachments Index

  • DQ Protocol Document
  • IQ Protocol Document
  • OQ Protocol Document
  • PQ Protocol Document
  • Calibration Data Reports

Approvals

Prepared by: [Name, Title]

Reviewed by: [Name, Title]

Approved by: [Name, Title]

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