Validation

The FDA, Health Canada, MHRA, EMA, and other regulatory bodies require regulated companies to perform computer systems validation (CSV) on any software system used to collect, store, analyze, report or transfer data in the place of paper data in cGMP, cGLP, and cGCP environments.

CSols’s validation experts understand the science, manufacturing, infrastructure, and instrumentation as well as the regulatory agency audit processes and can tailor validation services to each client to reduce validation risk.

Clients tell us that their laboratory informatics systems, instrument systems, and computing environments were compliant and defensible more quickly and with fewer resources when compared to their experiences with generic CSV consultants.

Our multi-disciplinary CSV consultants speak the language of your business, your IT department, and your manufacturing execution system (MES) as well as your laboratory informatics systems (LIMS, ELN, LES) and instruments.

This in-depth understanding reduces knowledge transfer time and gets your project started rapidly: we can quickly understand your regulatory needs, manufacturing environment, laboratory informatics and instrument systems, business and laboratory processes, information and data workflows, and how your computer systems and manual processes bring all those activities together.

Our understanding of real-world regulatory agency practices allows us to effectively and efficiently help you plan, implement, and verify a fully compliant, defendable system in any regulated computing environment.

CSols delivers CSV services using the GAMP®5 risk-based approach. We can assist you during any project stage, from concept to planning and executing, through operation and upgrades, and even system retirement.