Validation Summary Report (VSR)
Equipment Information
Equipment: PW Storage Tank
Subcategory: Utilities (Water Systems)
Area: Utilities
Validation Flags
DQ: Yes
IQ: Yes
OQ: Yes
PQ: Yes
Acceptance Criteria Reference
Reference: URS Annex15
Key Critical Parameters
Parameters: Temp level microbial integrity
Requalification Frequency
Frequency: 12 Months
Summary
This Validation Summary Report outlines the validation activities conducted for the PW Storage Tank in the Utilities area, ensuring compliance with URS Annex15 and maintaining critical parameters for microbial integrity.
Scope and Boundaries
The scope of this validation includes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the PW Storage Tank. The boundaries encompass all associated utilities and systems impacting the tank’s performance.
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 per the predefined criteria.
CPP Verification Summary
All critical process parameters (CPPs) related to temperature and microbial integrity were verified during the qualification phases, ensuring compliance with established acceptance criteria.
Conclusion
The validation of the PW Storage Tank has been successfully completed in accordance with applicable regulations and standards. The system is qualified for use, with a requalification frequency set at 12 months.
Attachments Index
- Executed Protocols
- Deviation Reports
- Verification Records
Approvals
Prepared by: [Name]
Approved by: [Name]
Date: [Date]