1. [Home](https://www.g2.com/) 2. ... 3. [AI Governance Tools](https://www.g2.com/categories/ai-governance-tools) 4. [INGENEUS Discussions](https://www.g2.com/products/ingeneus/discuss) [ ![Product Avatar Image](https://images.g2crowd.com/uploads/vendor/image/1984288/large_detail_e34d078a087ce18c58b33c5cb67d07ce.png "Product Avatar Image") ](/products/ingeneus/reviews) [ INGENEUS ](/products/ingeneus/reviews) 0 ratings INGENEUS is an AI-powered GxP (Good Practice) excellence platform designed to unify Quality Management Systems (QMS), Regulatory Information Management (RIM), Manufacturing, and Clinical operations within the life sciences, pharmaceutical, medical device, and biotech industries. By integrating these critical functions into a single, intelligent platform, INGENEUS streamlines compliance processes, enhances operational efficiency, and accelerates innovation. Key Features and Functionality: - Quality Management (QMS): Manages CAPA (Corrective and Preventive Actions), document control, change management, audit management, training, and complaint handling, all enhanced with AI capabilities. - Regulatory Information Management (RIM): Facilitates the management of submissions, registration dossiers, labeling, and agency correspondence across multiple global markets from a centralized workspace. - Manufacturing Excellence: Provides electronic batch records, deviation management, process controls, material management, and real-time GMP (Good Manufacturing Practice) compliance monitoring. - Clinical Operations: Supports IND/IDE applications, investigator site management, protocol deviations, safety reporting, and electronic Trial Master File (eTMF) management. - Supplier Management: Enables supplier qualification, risk-based monitoring, quality agreements, audits, and Supplier Corrective Action Request (SCAR) management with AI-driven risk scoring. - Product Development: Covers design control, risk management (ISO 14971), Design History File (DHF)/Device Master Record (DMR), verification and validation, and design transfer with full traceability. Primary Value and User Solutions: INGENEUS addresses the complexities of GxP compliance by providing an integrated, AI-native platform that automates and enhances critical processes across quality, regulatory, manufacturing, and clinical domains. By leveraging intelligent automation, predictive analytics, and real-time risk assessment, the platform helps organizations: - Reduce time-to-market for new products by streamlining compliance workflows. - Enhance data integrity and traceability across all operations. - Improve decision-making through AI-driven insights and predictive risk management. - Ensure adherence to global regulatory standards, including 21 CFR Part 11, ISO 13485, and EU GMP. By unifying these functions, INGENEUS empowers life sciences organizations to maintain compliance, mitigate risks, and drive innovation more effectively. Show More When users leave INGENEUS reviews, G2 also collects common questions about the day-to-day use of INGENEUS. These questions are then answered by our community of 850k professionals. Submit your question below and join in on the G2 Discussion. * * * ### 0.0 Nps Score ### All INGENEUS Discussions Search Most CommentedMost HelpfulCommon QuestionsNewest All DiscussionsDiscussions with CommentsCommon QuestionsDiscussions without Comments FilterFilter Filter byExpand/Collapse Sort by Most Commented Most Helpful Common Questions Newest Filter by All Discussions Discussions with Comments Common Questions Discussions without Comments Sorry... There are no questions about INGENEUS yet. ## Start a New Software Discussion Have a software question? Get answers from real users and experts [Start A Discussion](/products/ingeneus/discussions/new?entry_point=discussions%23product) * * * ![Product Avatar Image](https://images.g2crowd.com/uploads/vendor/image/1984288/thumb_square_e34d078a087ce18c58b33c5cb67d07ce.png "Product Avatar Image") ### Have you used INGENEUS before? Answer a few questions to help the INGENEUS community [ Yes ](javascript:void(0))[ Yes ](https://www.g2.com/login?context=product_review&return_to=https%3A%2F%2Fwww.g2.com%2Fproducts%2Fingeneus%2Fdiscuss%3Fsmall_ask%3Dingeneus) No