In the life sciences industry, Qualification is the cornerstone of regulatory compliance and operational integrity. It is the documented proof that your equipment, systems, and processes are suitable for their intended use and consistently produce results that meet predetermined specifications. Our Qualification specialists ensure your facility and its critical components are fully validated and audit-ready.
Achieving compliance with stringent regulations in a GxP facility is a complex task. Adopting a risk-based approach is the key to project success and a smooth equipment turnover. With Genesis, you’re ready for manufacturing and quality release operations on day one. Our qualification and validation experts apply their hands-on industry knowledge to guide you through the process, taking time to learn “what you do” and “how you do it.”
Our expertise spans the entire qualification lifecycle, from initial planning to execution and final reporting, adhering to global regulatory standards such as FDA’s 21 CFR Part 210, 211, and European GMP guidelines.
Our validation professionals provide swift issue identification and resolution, and adeptly navigate regulatory hurdles. We’re well-versed in current standards such as FDA, EU, ISO, USP, and ISPE with proficiency in electronic validation and document control systems such as Kneat, eVal, and Trackwise. We excel in planning, reviewing, executing, validating, and turning over scientific and process equipment for use in GxP environments.
