Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities performed for the PLC System utilized in the Production area, ensuring compliance with regulatory requirements and internal standards.

Scope and Boundaries

The validation activities encompass the entire lifecycle of the PLC System, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The boundaries are defined by the manufacturing processes that utilize the PLC System for automation.

Executed Protocol List

• DQ Protocol
• IQ Protocol
• OQ Protocol
• PQ Protocol

Deviations Summary

No deviations were reported during the validation activities. All protocols were executed as planned, adhering to the acceptance criteria specified in the URS Annex 11 and 21 CFR Part 11.

CPP Verification Summary

The following key critical parameters were verified:

• Logic execution
• Alarms
• Audit trail
• Access control

All parameters met the acceptance criteria established in the validation protocols.

Conclusion

The PLC System has been successfully validated in accordance with the regulatory requirements and internal validation standards. The system is deemed suitable for use in the production environment, with requalification scheduled after any significant changes.

Attachments Index

• Attachment 1: DQ Protocol Report
• Attachment 2: IQ Protocol Report
• Attachment 3: OQ Protocol Report
• Attachment 4: PQ Protocol Report

Approvals

This Validation Summary Report has been reviewed and approved by the following personnel:

• Name: [Approver Name], Title: [Approver Title], Date: [Approval Date]
• Name: [Reviewer Name], Title: [Reviewer Title], Date: [Review Date]