For the average business, managing the site quality validation function is a complex process to assure effective oversight of facility, equipment, utility, method, computerized systems, and process validation. At Xevalics, we follow our proven agile streamlined risk-based approach to make certain your site compliance with policies, procedures, and tools to ensure your regulated (GxP) systems are validated and controlled in accordance with the applicable US and EU GMP regulations and ICH guidelines. Our expert consultants have a thorough understanding of global regulations and industry-accepted software development standards.
With the new FDA CSA Guidance soon to be released, Xevalics will support your organization implementing CSA through agile project management, incremental adoption strategies, and strategic change management for an effective transition at your site. Xevalics consultants will help validate your equipment, systems, software, facilities, utilities, test methods, processes, and more. From remediation to facility expansions to quality initiatives, our team specializes in bringing solutions to complex problems across the pharmaceutical, biotech, and cell & gene therapy industries. Our team focus is on delivering excellence.