Best bang for the buck of any electronic QMS out there. Intuitive organization and interface, similar in concept to the traditional paper QMS; learning curve is minimal for users already experienced in Quality. Excellent, responsive customer service. Simple implementation.
At BioEthica, we are committed to maintaining the highest standards of quality and regulatory compliance across all our FDA-regulated projects. After evaluating several well-known platforms, we selected Kivo to support our own internal Quality Management System (QMS), Regulatory Information Management (RIMs), and client-facing documentation workflows. The result has been an exciting experience, and we've recommended Kivo to our clients too, also implementing Kivo solutions.
We also love Kivo’s seamless, user-friendly dashboard. It’s visually intuitive and logically organized, making it easy to navigate even for first-time users. The platform’s usability and customization options have made it easy to tailor Kivo to our specific needs.
What truly elevates the Kivo experience is their excellent customer service and support team, who are responsive, knowledgeable, and genuinely committed to our success. From onboarding to troubleshooting, their team has been a reliable partner at every step. The personnel are fun, smile, are polite and polished. The training provided was top-notch—clear, efficient, and tailored to our users’ needs—ensuring smooth adoption across the board.
Looking ahead, we’re excited to see Kivo launch their eTMF solution. Given their track record, product quality, and the smoothness of our own BioEthica implementation, we are confident this new feature will stand shoulder-to-shoulder with the top eTMF systems commercially available today. With Kivo’s expertise, commitment to usability, and flexible platform, we’re certain their eTMF will be another industry standout.
In short, Kivo has become an indispensable part of our digital infrastructure. Its powerful functionality, intuitive design, and outstanding support have exceeded our expectations. We highly recommend Kivo to any organization looking for scalable, compliant, and collaborative regulatory and quality solutions.
Kivo is a great tool for small organizations to store both business as well as regulatory documents. The system is user friendly and minimal training is required to become proficient to use the system. The folder structure is easy to follow so no documents get lost. Collaboration enables a distributed (remote) team to work together in real time to complete document content. Building regulatory submissions is a snap. The system eliminates excel spreadsheets and other trackers and the project management features provide a great summary view into content and submission planning, preparation, and completion. It's a "must have" for small companies preparing their first IND and scales well for small and mid-sized companies looking to prepare NDAs/BLAs/501Ks.
Kivo is building the infrastructure for GxP compliance in the era of AI-powered drug development. Its unified cloud platform supports Regulatory, Clinical, and Quality operations — including RIM, eTMF, QMS, controlled document management, submission assembly, eCTD lifecycle management, inspection readiness, SOP management, and training management — within a single, audit-ready environment. With Part 11-compliant e-signatures, role-based permissions, continuous validation assurance, and a lossless data model that preserves context from legacy systems, Kivo gives life sciences teams the compliant foundation to reduce operational friction and accelerate time to market.
For more information, visit: https://kivo.io/.