Validation Summary Report (VSR)
Equipment: Zeta Potential Analyzer
Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP)
Area: QC/R&D
DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes
Acceptance Criteria Reference: URS Annex11
Requalification Frequency: 12 Months
Summary
This Validation Summary Report provides an overview of the validation activities performed for the Zeta Potential Analyzer, ensuring compliance with regulatory requirements and internal quality standards.
Scope/Boundaries
The scope of this validation encompasses the installation, operational, and performance qualifications of the Zeta Potential Analyzer utilized in the QC/R&D area for critical NDDS analytics.
Executed Protocol List
- DQ Protocol
- IQ Protocol
- OQ Protocol
- PQ Protocol
Deviations Summary
No significant deviations were noted during the validation process. All activities were conducted in accordance with the approved protocols.
CPP Verification Summary
The critical parameters verified during the validation include:
- Accuracy
- Repeatability
- Audit Trail
All parameters met the acceptance criteria as outlined in the URS Annex11.
Conclusion
The validation activities for the Zeta Potential Analyzer have been successfully completed, demonstrating that the equipment operates within specified limits and is suitable for its intended use in the QC/R&D area.
Attachments Index
- Executed Protocols
- Validation Data and Results
- Change Control Documentation
- Training Records
Approvals
This report has been reviewed and approved by the following individuals:
- Quality Assurance Manager: ______________________
- Validation Lead: ______________________
- Department Head: ______________________