Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Barcode Scanner utilized in the Production/Dispensing area for Solid Dosage Forms (OSD). The report includes a summary of the executed protocols, deviations, critical parameter verification, and overall conclusions regarding compliance with URS Annex 11 and 21CFR11.

Scope and Boundaries

The scope of this validation encompasses the installation, operational, and performance qualification of the Barcode Scanner used in the Production/Dispensing area. The boundaries include the equipment’s interaction with the solid dosage forms and its integration within the existing production systems.

Executed Protocol List

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Deviations Summary

No deviations were recorded during the execution of validation protocols. All tests and inspections were conducted as per the established protocols and acceptance criteria.

CPP Verification Summary

The key critical parameter verified during the validation process was the scan accuracy data capture audit trail. The equipment consistently met the acceptance criteria outlined in the URS Annex 11 and 21CFR11.

Conclusion

The validation activities for the Barcode Scanner have been successfully completed. The equipment is compliant with regulatory requirements and is suitable for use in the Production/Dispensing area for solid dosage forms. Requalification will be performed after any changes to the equipment or processes.

Attachments Index

• Executed Protocols
• Validation Test Results
• Calibration Certificates
• Change Control Documentation

Approvals

Validation Team Lead: ______________________ Date: ____________

Quality Assurance Manager: ______________________ Date: ____________