[CSV Column] Issue 4: Announcement of Points to Consider in Test Strategy and Implementation
We have published the fourth installment of our partner company CAC's contributed column series titled "Points Customers Often Overlook and Unexpected Challenges." The fourth installment focuses on "Performance Qualification (PQ)."
PQ (Performance Qualification) is the final quality confirmation process conducted before the start of operations to verify and demonstrate that the system can consistently operate as intended in accordance with actual business procedures and regulatory requirements. In this column, we will explain practical points to ensure that PQ goes beyond mere functional confirmation to appropriately demonstrate business suitability and quality.
■ Key Points
- Considerations for PQ test planning based on business scenarios
- Key aspects of validation including data integrity and ER/ES requirements
- Realism of test data and the differentiation between positive and negative testing
- Principles for maintaining test records that can withstand audits
- How to assess and manage deviations that occur during PQ
■ Column Agenda
1. Test planning and evaluation policy in PQ
2. Importance of test data
3. Creation and maintenance of accurate test records
4. Pitfalls in deviation management
5. Summary

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