Computer System Validation (CSV) Services

White Paper: "What is Computer System Validation (CSV) and Why is it Important?"

CSols’ processes, combined with our experts’ skills and knowledge, consistently deliver peace-of-mind through fully defensible laboratory informatics and instrument systems.

We develop:

On Target Risk Assessments

Once we have an understanding of risk probability, severity, and detectability, we can effectively mitigate risks in the CSV process. We identify specific functions and features that should be tested and optimize the testing level for each. CSols risk assessments feed into validation plans that are compliant and efficient.

System Specific Validation Plans

We create validation plans that are custom to each client: experience has taught us that generic plans are not one size fits all. CSols experts work closely with client teams to understand business and data processes to create a validation plan that incorporates CSV best practices and clients’ specific needs.

Thorough Test Scripts

Test scripts are the center of the CSV process and must completely exercise your requirements and system specifications to prove intended use. CSols experts have decades of experience writing test scripts unique to how each customer uses laboratory informatics in their environments. Our scripts leverage our knowledge of clients’ business and laboratory needs to minimize risks, cost, and time required.

Detailed Documentation and Reports

Clear and concise CSV lifecycle documentation following a GAMP®5 risk-based approach makes your systems defensible during an audit. CSols documentation stands up to auditors’ scrutiny so you can feel confident in your laboratory computer systems and therefore your laboratory data.

CSols validation experts support a full range of validation activities:

  • Validation planning
    • Develop system-specific validation plans
    • Conduct and inventory of hardware and software systems
    • Develop user requirements specifications (URS)
    • Develop functional requirements specifications (FRS)
    • Develop system configuration specifications
    • Develop system design specifications
    • Perform functional and quality risk assessments
    • Perform vendor audits
  • Testing
    • Execute hardware installation qualifications
    • Execute software installation qualifications
    • Develop software installation, operation, and performance qualifications (IQ OQ PQ)
    • Execute IQ OQ PQ scripts
    • Develop a traceability matrix
    • Implement system configuration
  • Go-live preparation and reporting
    • Develop validation and testing summary report
    • Create system release documentation
    • Create and/or update standard operating procedures
    • Create data migration and verification plans
    • Execute data migrations and verifications
    • Decommission legacy systems

We provide peace-of-mind during project planning and execution by assigning the right resource to fit your needs. CSols experts include experienced CSV project managers, team leaders, and subject matter experts to support your project from beginning to end and allow laboratory staff to stay focused on their daily activities.

CSols specialized knowledge and expertise can support your validation project.