Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) provides an overview of the validation activities performed for the NDDS Process Control System, encompassing the PLC/SCADA used for microfluidics, homogenization, and tangential flow filtration (TFF). The report outlines the validation lifecycle including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with URS Annex 11 and 21 CFR Part 11 compliance.

Scope/Boundaries

The scope of this validation includes the NDDS Process Control System utilized within the Production area. The boundaries of this validation encompass the software and hardware components of the PLC/SCADA system, focusing on critical parameters such as audit trail access control, recipe management, and data integrity.

Executed Protocol List

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

Deviations Summary

During the validation activities, no significant deviations were noted that would impact the integrity of the validation outcomes. All protocols were executed as per the approval criteria.

CPP Verification Summary

Key critical parameters (CPPs) were verified during the qualification phases. The following were confirmed:

• Audit Trail Access Control: Verified compliance with access control requirements.
• Recipe Management: Confirmed proper configuration and execution of recipes.
• Data Integrity: Ensured data integrity measures were in place and effective.

Conclusion

The NDDS Process Control System has been successfully validated in accordance with the established protocols and regulatory requirements. It is deemed suitable for its intended use in the production area, adhering to the necessary compliance standards.

Attachments Index

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

Approvals

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

• Quality Assurance Manager: [Name]
• Validation Lead: [Name]
• Production Manager: [Name]