CSols’ Computer System Validation (CSV) team is comprised of highly skilled scientists, information technologists, and regulatory experts who specialize in scientific computer system validation. Our multi-disciplinary CSV consultants speak the language of your business, your laboratory, your IT department, and your laboratory informatics systems.
This means we quickly understand your laboratory informatics and lab instrument systems, business and laboratory processes, information and data workflows, and how your computer systems are incorporated in what you do. Furthermore, CSols’ computer systems validation consultants are regulatory experts who keep abreast of the ever growing number of regulations such as: GMP / CGMP, GLP, GCP, Annex 11, ISO 17025, ISO 15189, 21 CFR Parts 11, 58, 210, 211 and 820, ASTM Standard E2500, CLIA, etc. to determine how they may affect your CSV project. We also understand the real-world practices of the regulatory agencies which allows us to effectively and efficiently help you plan, implement, and verify a fully compliant, defendable laboratory informatics and computing environment.
CSols’ CSV services are delivered utilizing the GAMP 5 Risk-Based approach and Software Categories. We can assist you during any project stage, from conceptualizing your CSV project, to planning and executing, through operation, upgrades and enhancements, to finally retiring your system.
We will ensure you have the right level of resource to fit your need. CSols can provide a CSV Project Manager to ensure your project runs smoothly, is on time, and meets all compliance and business needs. We can provide a CSV Lead to handle all validation activities and deliverables required for your project. And we can augment your team with SMEs to develop specific documents (e.g., User Requirements, Specifications, Test Scripts/Protocols, etc.) and execute testing, allowing your laboratory staff to remain focused on their daily activities.
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If you’d like to discuss your options and needs for Computer Systems Validation, we’d be happy to talk one-on-one with you. Click the button to send us a message and we will have the appropriate person reach out to you.