Validation Summary Report (VSR)

Summary

This Validation Summary Report documents the validation activities performed for the SCADA System used in the Production area. The validation encompasses Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with URS Annex 11 and 21 CFR Part 11.

Scope and Boundaries

The scope of this validation includes the assessment of the SCADA System’s functionalities related to manufacturing automation. The boundaries of the validation encompass all critical parameters, including audit trail, alarms, data integrity, and access control.

Executed Protocol List

• DQ Protocol – SCADA System
• IQ Protocol – SCADA System
• OQ Protocol – SCADA System
• PQ Protocol – SCADA System

Deviations Summary

No significant deviations were noted during the validation process. All protocols were executed as per the defined procedures.

CPP Verification Summary

Key critical parameters verified during the validation include:

• Audit Trail: Confirmed functionality and compliance with data integrity requirements.
• Alarms: Verified alarm functionality and response times.
• Data Integrity: Assessed validation of data storage and retrieval processes.
• Access Control: Evaluated user access levels and security measures.

Conclusion

The validation of the SCADA System has been successfully completed, demonstrating compliance with regulatory requirements and established acceptance criteria. The system is deemed suitable for use in the Production area.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: Validation Summary Report Approval Signatures

Approvals

This report has been reviewed and approved by the following personnel:

• Quality Assurance Manager: ____________________
• Validation Lead: ____________________
• Production Manager: ____________________