Validation Summary Report (VSR)

Equipment: Nano Tracking Analysis (NTA) System

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: Accuracy, Data Integrity, Audit Trail

Requalification Frequency: 12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Nano Tracking Analysis (NTA) System in the QC/R&D area. The purpose of this report is to confirm that the system meets the necessary requirements and is suitable for its intended use.

Scope/Boundaries

The validation activities encompass the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the NTA System. The scope includes all critical parameters as defined in the URS Annex11.

Executed Protocol List

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

Deviations Summary

No deviations were recorded during the validation process. All protocols were executed as per the defined parameters and acceptance criteria.

CPP Verification Summary

Critical Process Parameters (CPP) were verified through appropriate testing and monitoring during the OQ and PQ phases. All results met the acceptance criteria outlined in the URS Annex11.

Conclusion

The Nano Tracking Analysis (NTA) System has successfully passed all validation phases (DQ, IQ, OQ, PQ) and is deemed compliant with regulatory requirements. The system is approved for use in QC/R&D activities.

Attachments Index

• Executed DQ Protocol
• Executed IQ Protocol
• Executed OQ Protocol
• Executed PQ Protocol
• Validation Summary Report

Approvals

Validated by: [Name, Title, Date]

Approved by: [Name, Title, Date]