Validation Summary Report (VSR)

Equipment:

HMI System (Human Machine Interface)

Subcategory:

Computerized Systems (Manufacturing Automation)

Area:

Production

DQ/IQ/OQ/PQ Flags:

Design Qualification: Yes

Installation Qualification: Yes

Operational Qualification: Yes

Performance Qualification: Yes

Acceptance Criteria Reference:

URS Annex11 21CFR11

Key Critical Parameters:

Audit trail operator access control system integrity

Requalification Frequency:

After Change

Summary:

The validation of the HMI System has been conducted to ensure compliance with regulatory requirements and operational integrity. This report summarizes the validation activities performed and their outcomes.

Scope/Boundaries:

This validation covers the HMI System utilized in the Production area, focusing on its functionalities related to manufacturing automation and compliance with 21CFR11.

Executed Protocol List:

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

Deviations Summary:

No deviations were noted during the execution of the validation protocols. All tests were performed as per the approved protocols.

CPP Verification Summary:

Critical Process Parameters (CPPs) related to audit trail and operator access control were verified and found to be compliant with the acceptance criteria.

Conclusion:

The validation of the HMI System is complete, and the system is deemed qualified for use in the Production area. It meets all regulatory and operational requirements.

Attachments Index:

Attachment 1: DQ Protocol
Attachment 2: IQ Protocol
Attachment 3: OQ Protocol
Attachment 4: PQ Protocol
Attachment 5: Validation Plan

Approvals:

__________________________
Validation Lead

__________________________
Quality Assurance

__________________________
Production Manager