Validation Summary Report (VSR)

Equipment: Purified Water Generation System (PW System)

Summary

This Validation Summary Report outlines the validation activities conducted for the Purified Water Generation System (PW System) in accordance with the established protocols and acceptance criteria. The system has been validated for compliance with URS Annex 11 and Annex 15 standards.

Scope / Boundaries

The scope of this validation encompasses the design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of the PW System. The boundaries include the entire water generation process and associated utilities.

Executed Protocol List

DQ Protocol
IQ Protocol
OQ Protocol
PQ Protocol

Deviations Summary

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

CPP Verification Summary

The following critical parameters were verified:

Conductivity
TOC (Total Organic Carbon)
Flow Rate
Temperature
Pressure
Audit Trail

All parameters met the established acceptance criteria as per URS Annex 11 and Annex 15.

Conclusion

The Purified Water Generation System has been successfully validated. It meets all critical parameters and is compliant with the relevant regulatory standards. The system is approved for use and will undergo requalification every 12 months.

Attachments Index

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

Approvals

Prepared by: ___________________ (Name, Title)

Reviewed by: ___________________ (Name, Title)

Approved by: ___________________ (Name, Title)