Computerized System Validation (CSV)
Validation activities provide a high degree of assurance to ensure patient safety, product quality, and data integrity.
CSV
Validation Planning
Writing a Plan for your software validation activities with regards to the validation scope, strategic and testing methodology, while using a risk-based approach
URS(SRS)/FRS
Learning your Software and defining system requirements and functional requirements
Software Design Specification
Defining the software design specifications
Risk analysis
Analyzing software-associated risks and risk prioritization and defining controls and measures to the risk related to regulatory requirements and user requirements and the necessary mitigations
Test Protocols
IQ, OQ, PQ protocols- Customizing Validation testing templates for writing the IQ/OQ/PQ validation protocols. – IQ, OQ, PQ execution- Performing the validation testing based on pre-approved protocols and documenting all validation results in real-time
Validation Summary Report
Summarizing all of the validation activities and generating a final report which qualifies the system as valid and ready for use /Not valid and what corrections are needed
Traceability Matrix
Gathering all validation data references from the requirement to testing level and assuring complete coverage of the system requirements
Data Migration
Data Migration Activities
- Planning – writing the Data Migration Plan when transferring the data Qualification protocol
- Testing – writing and executing tests that ensure the data was transferred correctly
- Report – data was transferred correctly, and you can retire the old system
Training
CSV Training
Delivering professional CSV training courses and presentations for your CSV team
Supporting Documentation
Writing CSV Supporting Documentation
- CSV Policy
- Software Risk assessment
- Computerize System Requirements and Risk Assessment
- Periodic System Review
- Audit Trail Periodic Review
- Inventory list
Data Integrity
Data Integrity
- Training on Data integrity, how it is enforced in computerized systems
- Verify that the system support Data integrity requirements
CSV audit readiness / Gap analysis
CSV audit readiness / Gap analysis
We offer our customers a complete and thorough analysis of the CSV status.
The gap analysis includes risk based approach, classification and writing a mitigation plan.
Supporting Documentation review – verifying and reviewing CSV supporting Documentation validation polices and SOP’s checking that all documentations are in place and that they are up to industry standard
Computerized system review
▪ will determent if the system is compliance with the Data integrity requirements.
▪ reviewing validation documentation and verifying that it covers regulatory requirements, verify that there are no gaps that were not solved,
verify that there were no system updates since the last validation
