Quality management in the pharmaceutical and biotechnology industry goes beyond ISO expectations with its complexity and demands for significant investments of time, energy, and resources. In an effort to meet challenging and multifaceted FDA regulations, as well as other international regulations, pharmaceutical and biotech companies are investing significant resources in the development and implementation of an effective Quality Management System (QMS). Novatek’s Quality Management System, Nova-QMS is a comprehensive solution designed to address pharma and biotech’s most pressing quality business issues including documentation, corrective and preventive action procedures, change controls, training, production validation, and complaint management. Nova-QMS Key functions Include: • Manages all internal & external audit documentation • Configurable reporting & query tools for data retrieval & knowledge management • Powerful CAPA (Corrective Action & Preventive Action) functionalities • Compliant with 21 CFR Part 11 & other key regulatory requirements • Secures access to all documents including SOP’s, change controls, investigation repo deviations, validation documents & more • Automated scheduling Nova-QMS Key benefits include: • Integrates all procedures creating harmonization within a seamless quality process • Enables quality regulatory compliance & increases operational efficiency • Increases & improves communication between cross-functional departments & knowledge sharing management • Foresees & reduces risk with early detection methods • Reduces human error • Provides full traceability of quality issues • Reduces recall costs with an improved automated quality program