Validation Summary Report (VSR)
Equipment Information
Equipment: Viscometer / Rheometer
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
Key Critical Parameters: Accuracy, Repeatability, Audit Trail
Requalification Frequency: 12 Months
Summary
This Validation Summary Report provides an overview of the validation activities conducted for the Viscometer/Rheometer used in the QC/R&D area. The validation process aimed to ensure compliance with regulatory standards and internal quality requirements.
Scope/Boundaries
The scope of this validation encompasses the installation, operational, and performance qualifications of the Viscometer/Rheometer. It includes all critical parameters and performance metrics as defined in the URS and related documentation.
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 performed in accordance with the established protocols.
CPP Verification Summary
All Critical Process Parameters (CPPs) were verified and found to be within the acceptable limits as defined in the URS. The accuracy and repeatability of the equipment were confirmed through rigorous testing.
Conclusion
The validation of the Viscometer/Rheometer is deemed successful, and the equipment is qualified for use in the QC/R&D area. It meets all specified requirements and is compliant with relevant regulatory standards.
Attachments Index
- Executed DQ Protocol
- Executed IQ Protocol
- Executed OQ Protocol
- Executed PQ Protocol
- Validation Summary Report
Approvals
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Validation Lead
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Quality Assurance