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