Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) provides an overview of the validation activities conducted for the Cold Room (2–8°C) used for raw material storage in the warehouse. The report encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, ensuring compliance with the acceptance criteria outlined in URS Annex 11 and Annex 15.

Scope and Boundaries

The scope of this validation encompasses the Cold Room utilized for the storage of raw materials within the warehouse area. The boundaries include the physical structure, temperature monitoring systems, and associated alarm systems.

Executed Protocol List

• DQ Protocol – Cold Room
• IQ Protocol – Cold Room
• OQ Protocol – Cold Room
• PQ Protocol – Cold Room

Deviations Summary

No deviations were noted during the execution of the validation protocols. All activities adhered strictly to the predefined protocols and acceptance criteria.

CPP Verification Summary

The key critical parameters (CPP) were verified as follows:

• Temperature Mapping: Successfully completed with all readings within the specified range (2–8°C).
• Alarms: Functionality tested and confirmed operational.
• Audit Trail: Verified for compliance with regulatory requirements.

Conclusion

The Cold Room (2–8°C) has been successfully validated in accordance with the established protocols and acceptance criteria. It is deemed suitable for the storage of raw materials, with a requalification frequency of 12 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document
• Attachment 5: Temperature Mapping Report
• Attachment 6: Alarm Functionality Test Report

Approvals

Prepared by: [Name], [Title], [Date]

Reviewed by: [Name], [Title], [Date]

Approved by: [Name], [Title], [Date]