In our last blog, we shared a brief introduction to the concept of CSV (Computer System Validation) and CSA (Computer System Assurance). Both of which are highly critical processes in the life sciences industry, that ensure the reliability and integrity of computer systems used in regulated environments. While they share similar goals, there are distinct approaches and requirements.
To better understand what these system validation processes are in-depth and which one can potentially be a right fit for your business, let’s discuss a few key differences and major steps involved.
Key Differences Between CSV and CSA are as follows:
| CSV | CSA |
| Focuses on validation through extensive documentation and testing of all system functionalities. | Emphasizes on critical thinking and risk-based assurance, prioritizing patient safety, product quality, and data integrity over exhaustive documentation. |
| Typically limited to specific systems | Broader, encompassing the entire IT infrastructure |
| More rigid and structured | More flexible and risk-based |
| Primarily FDA 21 CFR Part 11 | Includes FDA 21 CFR Part 11, GAMP 5, and other industry standards |
Now that we know in simple words what sets CSV apart from CSA, let’s further zoom into the difference between in steps and phases of each.
| Sr.No. | Phase | Step | CSV Process | CSA Process |
| 1. | Planning & Analysis Phase | Planning Phase | System Identification: Identify the software system (e.g., ERP, LIMS). Validation Plan: Create a validation master plan defining scope, deliverables, and roles. |
Risk Assessment: Identify and assess risks to patient safety, product quality, and data integrity. Assurance Plan: Develop a plan focusing on critical functionalities and areas of high risk. |
| Requirements Gathering | User Requirements Specification (URS): Document all user and functional requirements. | Critical Thinking: Focus on the critical functions that directly impact patient safety and quality. | ||
| System Design Review | Design Qualification (DQ): Verify that the system design meets the user requirements and is compliant with regulations. | Fit-for-Purpose Review: Ensure system functionalities that affect quality and safety are fit for purpose. | ||
| Risk Assessment | Risk Analysis: Conduct a formal risk assessment for the entire system. | Targeted Risk-Based Approach: Perform a risk based assessment focusing only on critical areas. | ||
| 2. | Testing & Documentation Phase | Testing Strategy | Test Planning: Develop a comprehensive test plan covering all system functionalities, regardless of criticality. | Risk-Based Testing: Focus testing on high risk areas that impact product quality and patient safety. |
| Installation Qualification (IQ) | Installation Qualification (IQ): Verify correct installation of hardware and software per vendor specifications. | Critical Component Verification: Validate installation of components critical to system performance. | ||
| Operational Qualification (OQ) | Operational Qualification (OQ): Ensure that the system functions as expected under all possible conditions. | Critical Function Testing: Test only key functions that have an impact on quality and safety. | ||
| Performance Qualification (PQ) | Performance Qualification (PQ): Validate that the system performs as required in the live production environment. | Performance Assurance: Focus on high-risk use cases in real-world conditions to ensure system reliability. | ||
| Documentation | Extensive Documentation: Maintain detailed documentation for all validation activities, following a formal validation lifecycle. | Streamlined Documentation: Prioritize concise documentation that supports critical quality assurance efforts. | ||
| 3. | Review and Approval Phase | Review and Approval | Formal Review and Sign Off: Conduct a formal review and approval process by cross functional teams. | Risk-Based Review: Ensure that the review process focuses on high-risk areas and patient safety impact. |
| 4. | Periodic Review Phase | Ongoing Monitoring | Periodic Review and Revalidation: Conduct regular system reviews to ensure continued compliance and performance. | Continuous Assurance: Implement continuous monitoring for critical system functions based on risk. |
| 5. | Change Management Phase | Change Control | Change Control Management: Follow a formal change control process for system updates and modifications. | Agile Change Management: Implement changes rapidly with risk based documentation and testing. |
Things To Consider While Choosing CSV or CSA:
- Regulatory Compliance: It is important to ensure that both CSV and CSA processes adhere to relevant regulations, such as FDA 21 CFR Part 11 and GAMP 5.
- Risk Management: Prioritization of risk-based approaches in both CSV and CSA to focus on critical areas.
- Documentation: Maintenance of comprehensive documentation for both processes to support audits and regulatory inspections.
Conclusion
Life sciences organizations can tailor their system validation processes to meet specific needs and regulatory requirements only after they can understand the difference between CSV and CSA. While the former offers a structured approach, CSA provides a more flexible and risk-based framework. By combining the strengths of both approaches in a hybrid form, organizations can achieve an efficient strategy that ensures data integrity, regulatory compliance, and overall system reliability.