Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) provides a comprehensive overview of the validation activities performed for the Distributed Control System (DCS) utilized in the Production area. The report includes details on Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, along with compliance to URS Annex 11 and 21 CFR Part 11.

Scope/Boundaries

The scope of this validation encompasses the DCS used for manufacturing automation within the Production area. The boundaries include all critical parameters related to system integrity, access control, and audit trail alarms.

Executed Protocol List

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

Deviations Summary

No deviations were reported during the qualification phases. All activities were conducted in accordance with the established protocols and acceptance criteria.

CPP Verification Summary

The following Critical Process Parameters (CPPs) were verified during the qualification process:

• Audit Trail
• Alarms
• System Integrity
• Access Control

Conclusion

The DCS has been successfully validated in accordance with the requirements set forth in the URS Annex 11 and 21 CFR Part 11. The system is deemed suitable for its intended use in the Production area, with requalification recommended after any significant changes.

Attachments Index

• Attachment A: DQ Protocol
• Attachment B: IQ Protocol
• Attachment C: OQ Protocol
• Attachment D: PQ Protocol
• Attachment E: Validation Summary Report

Approvals

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

• [Name], [Title], [Date]
• [Name], [Title], [Date]