Our CSV Approach

1. Risk Assessment: A risk-based approach is applied to evaluate the impact of systems on data integrity and product quality. This ensures efficient validation efforts focused on high-risk systems and processes.
2. User Requirements Specification (URS): Detailed, testable, and traceable requirements are defined to capture system functionality and compliance needs.
3. Validation Planning: A Validation Plan is developed to define scope, objectives, responsibilities, validation activities, and documentation deliverables.
4. Functional & Design Specifications (FS/DS): All technical and functional details of the system are documented to ensure alignment with the user requirements and provide a basis for testing.
5. Qualification Testing (IQ, OQ, PQ):
Installation Qualification (IQ): Verifies correct installation of hardware/software components.
Operational Qualification (OQ): Tests system functionality against specifications in a controlled environment.
Performance Qualification (PQ): Confirms consistent performance under real-world operating conditions.
6. Traceability Matrix: A traceability matrix maps each requirement to corresponding test cases to ensure complete coverage and validation transparency.
7. Validation Summary Report: A final report summarizes validation results, deviations (if any), and confirms that the system is fit for its intended use.
8. Change Control & Periodic Review: Validated systems are maintained under a robust change control process and subject to periodic reviews to ensure continued compliance.