Validation Summary Report (VSR)

Equipment Information

Equipment: WFI Storage Tank

Subcategory: Utilities (Water Systems)

Area: Utilities

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

Acceptance Criteria Reference: URS Annex15

Key Critical Parameters: Temp microbial integrity level

Requalification Frequency: 12M

Summary

This Validation Summary Report outlines the validation activities conducted for the WFI Storage Tank, ensuring compliance with regulatory requirements and internal standards.

Scope and Boundaries

The scope of this validation encompasses the design, installation, operation, and performance qualifications of the WFI Storage Tank within the Utilities area. This report includes all relevant documentation and protocols executed during the validation process.

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 performed as per the approved protocols.

CPP Verification Summary

The critical process parameters (CPPs) related to temperature and microbial integrity were verified and found to be within acceptable limits as defined in the acceptance criteria.

Conclusion

The validation of the WFI Storage Tank has been successfully completed in accordance with the established protocols and acceptance criteria. The system is deemed qualified for its intended use in the Utilities area.

Attachments Index

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

Approvals

_____________________
Validator Name
Title
Date

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Quality Assurance Name
Title
Date