Validation Summary Report (VSR)

Equipment Information

Equipment: TEM / SEM

Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP)

Area: QC/R&D

DQ/IQ/OQ/PQ Flags: Yes / Yes / Yes / Yes

Acceptance Criteria Reference: URS Annex11

Key Critical Parameters: Resolution calibration image integrity

Requalification Frequency: 24 Months

Summary

This Validation Summary Report outlines the validation activities and results for the TEM / SEM equipment used in the QC/R&D area, focusing on critical NDDS analytics.

Scope/Boundaries

The scope of this validation encompasses the installation, operational, and performance qualification of the TEM / SEM equipment, ensuring compliance with GMP standards and the specified acceptance criteria.

Executed Protocol List

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

Deviations Summary

No significant deviations were noted during the validation process. All protocols were executed as planned, adhering to the established acceptance criteria.

CPP Verification Summary

Key Critical Parameters were verified, focusing on the resolution calibration and image integrity, confirming that the equipment meets the required specifications.

Conclusion

The validation of the TEM / SEM equipment has been successfully completed, demonstrating compliance with the acceptance criteria outlined in URS Annex11. The equipment is deemed suitable for its intended use in critical NDDS analytics.

Attachments Index

• Executed Protocols
• Calibration Certificates
• Training Records
• Deviation Reports

Approvals

Prepared by: [Name], [Title]

Reviewed by: [Name], [Title]

Approved by: [Name], [Title]