# Kivo Reviews **Vendor:** Kivo **Category:** [Regulatory Information Management (RIM) Systems](https://www.g2.com/categories/regulatory-information-management-rim-systems) **Average Rating:** 4.9/5.0 **Total Reviews:** 20 ## About Kivo Kivo is the easiest-to-use compliant document and project management solution for Life Science companies, including Sponsors, CROs, Consultants, and Service Providers. Kivo's platform includes DMS, RIM, QMS, and eTMF functionality. CFR Part 11 Compliant e-Sign | Lifetime Validation | ISO 9001 Certified | SOC 2 Certified | TMF & EDM Reference Models | GxP Compliant ▶ For Regulatory • Customizable, automatic authoring, review, QC, and approval workflows • Real-time collaboration online or locally in Office 365 • Smart document placeholders, with pre-formatted ICH templates available • Assemble submissions from pre-built submission structures aligned to country guidelines • Create automated tracking spreadsheets for external publishing groups ▶ For Quality • Controlled document and SOP management that meets GxP standards • Training management linked directly to documents in the DMS • Build curricula for teams or individual users with documents, videos, and quizzes • Auto-fill quality forms with metadata • Manage change controls, CAPAs, Deviations, Audits, and Vendors ▶ For Clinical • Workflows mapped to the TMF reference model • Accelerate active trial management, from study start up and beyond • Migrate TMFs into the system in weeks, including recompiled audit trails • Real-time reporting into TMF completeness • Long-term TMF storage at a fraction of the typical cost, with automatic checksums to ensure data integrity • Separate inspector access to help streamline your trial narrative ## Kivo Pros & Cons **What users like:** - Users find Kivo to have an **intuitive interface** , making it easy to get started and use effectively. (7 reviews) - Users find **implementation exceptionally easy** with Kivo, enjoying intuitive design and strong customer support throughout the process. (6 reviews) - Users praise the **intuitive user interface** of Kivo, making it easy to navigate and implement in any organization. (5 reviews) - Users commend Kivo's **exceptional customer support** , noting their quick response times and helpful guidance during implementation. (4 reviews) - Users value the **customization options** of Kivo, enabling tailored functionalities to meet specific compliance needs efficiently. (4 reviews) - Features (3 reviews) - Document Management (2 reviews) - Intuitive (2 reviews) - Organization (2 reviews) - Collaboration (1 reviews) **What users dislike:** - Users find **feature limitations** frustrating, as some tools like electronic signatures require workarounds for usability. (1 reviews) - Users find **missing features** like incomplete electronic signatures requiring workarounds frustrating and inconvenient. (1 reviews) - Users find the **left side navigation confusing** , leading to challenges in effectively using Kivo's features. (1 reviews) ## Kivo Reviews ### 1. Intuitive Interface That Saves Time, Money, and Effort **Rating:** 4.5/5.0 stars **Reviewed by:** Andy W. | Manager, Regulatory Operations, Mid-Market (51-1000 emp.) **Reviewed Date:** May 05, 2026 **What do you like best about Kivo?** Not having to worry about Validation status saves a ton of time, money and effort. The interface is intuitive and people pick up on how to use it quickly. **What do you dislike about Kivo?** Needs to complete integration with Microsoft accounts, so features like @ mentions work the same way they do in Sharepoint. **What problems is Kivo solving and how is that benefiting you?** We have a simple, off-the-shelf solution that is Part 11 compliant, while allowing enough flexibility in how you structure your folders and how you track Regulatory Activities. ### 2. Intuitive, Fast, and Highly Customizable DMS with Exceptional Support **Rating:** 4.5/5.0 stars **Reviewed by:** Mike M. | VP Development and QC, Small-Business (50 or fewer emp.) **Reviewed Date:** May 05, 2026 **What do you like best about Kivo?** They have great customer service. The DMS is intuitive and fast. It's very customizable, and the support is some of the best I've ever experienced. **What do you dislike about Kivo?** It's objectively expensive, but it's very reasonable in it's market. **What problems is Kivo solving and how is that benefiting you?** We are a completely disbursed organization, so clinical trial and quality management would be almost impossible without Kivo. ### 3. KIVO: Intuitive, Fast, and Effortlessly Streamlines My Workflow at a low cost **Rating:** 5.0/5.0 stars **Reviewed by:** J K. | Manager, Mid-Market (51-1000 emp.) **Reviewed Date:** May 06, 2026 **What do you like best about Kivo?** I like KIVO because it’s easy to use, intuitive, and fast. Its straightforward design makes it simple to navigate, keeps my workflow streamlined, and lets me complete tasks efficiently without any unnecessary complexity. **What do you dislike about Kivo?** Nothing really stands out, but it’s a good system overall. **What problems is Kivo solving and how is that benefiting you?** It helps keep documents organized and easy to find. It also meets regulatory requirements and supports efficient study conduct. ### 4. Kivo is a QMS & RIMs game changer, excited for the TMF; competes strongly against its Goliath peers. **Rating:** 5.0/5.0 stars **Reviewed by:** Tara L. G. | Chief Executive Officer, Owner, Principal Consultant, Small-Business (50 or fewer emp.) **Reviewed Date:** April 30, 2025 **What do you like best about Kivo?** 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. **What do you dislike about Kivo?** We want to see even more and hope Kivo can get into more project management, tracking of project time against billables for SOWs (would be good for CDMOs, CROs and consultancies) and ESG submission solutions in the future, in short, the only thing we didn't like is that they don't offer more. **What problems is Kivo solving and how is that benefiting you?** Kivo’s QMS offers a streamlined, audit-ready environment that aligns seamlessly with our internal SOPs and external regulatory expectations. Document control, change management, training records, complaints, deviations/investigations and CAPA processes are centralized, customizable, offer compliance ease and would significantly improve a firms inspection readiness and our operational efficiency. The RIMs cabinets have proven invaluable in organizing complex regulatory submissions and product dossiers. With intuitive categorization, metadata tagging, and robust version control, our team can quickly access current and historical documents—ensuring accuracy, traceability, and confidence in all regulatory communications. To this regard, Kivo’s ability to serve up visibility to our clients with a viewing interface is another standout feature. As a consulting organization managing multiple clients with varying needs, we appreciate Kivo’s secure, permission-based access system. It allows us to provide clients with transparency into their documentation and project status—without compromising security or usability. This greatly enhances collaboration, and trust with our clients. ### 5. Best Value QMS with Intuitive Design and Outstanding Support **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Consulting | Small-Business (50 or fewer emp.) **Reviewed Date:** November 21, 2025 **What do you like best about Kivo?** 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. **What do you dislike about Kivo?** Some features (e.g., electronic signatures) are not completely built and require workarounds (e.g., Kivo-provided free Part 11 DocuSign for electronic signatures). **What problems is Kivo solving and how is that benefiting you?** Kivo provides document management, quality management, regulatory information management, and trial master file management all in a single package for an unbeatable price. ### 6. Great product with the right cost/complexity point **Rating:** 5.0/5.0 stars **Reviewed by:** Ken V. | CEO, Small-Business (50 or fewer emp.) **Reviewed Date:** August 14, 2024 **What do you like best about Kivo?** Kivo is a "right sized" tool that allows a life sciences company to establish and maintain compliance with regulated documentation practices without going overboard on complexity. Even better, the tool's integrated, but multiple module approach allows companies to customize what functions are used, allowing for a company to share documents across multiple groups, while keeping both cost and complexity to a minimum. In our organization, we've used multiple, but not all Kivo capabilities to deliver exactly the cloud-based functionality we need. It's straightforward enough that training is minimal and user uptake is very high with a short learning curve. The fact that it's deployed validated and Kivo maintains validation status as part of the model is invaluable. **What do you dislike about Kivo?** Increased use of drag and drop for document management functions (move, link, clone, etc) would be a really nice plus. **What problems is Kivo solving and how is that benefiting you?** Kivo allows us to share and collaborate on the authoring of documents securely and in a compliant environment. We also use the submissions tools to create submissions to FDA and the project management tools to help coordinate resources on complex projects. ### 7. Intuitive document management system that offers so much more **Rating:** 5.0/5.0 stars **Reviewed by:** Marissa B. | Senior Manager of Regulatory Strategy, Small-Business (50 or fewer emp.) **Reviewed Date:** August 12, 2024 **What do you like best about Kivo?** For context, I work in regulatory affairs/regulatory strategy/medical writing at a pharmaceutical company. My job involves regulatory document archiving, writing, and review, as well as planning/assembling submissions to health authorities. Keeping files organized and easy to find is a big deal for me. I have been using Kivo daily for over 2 years to manage 15+ drug development programs. It was extremely easy to learn and very intuitive for a regulatory affairs professional. We implemented Kivo at our small company of 35+ employees, which spans multiple countries and continents. The Kivo system has been easy to use for everyone. Kivo makes the process incredibly easy for file storage, document creation using their eCTD templates, document editing, collaborative authoring/review, submission building, and more, and we love how much it offers under a single vendor/software package. Other roles at my company make use of the eTMF and QMS systems within Kivo, and I'm looking forward to making use of some of the new project management features in Kivo. We rarely have any technical problems with Kivo, but on the rare occasion we do, the customer support team is very quick to respond and resolve the issue. They are always happy to answer any questions or teach me new features that have been added to Kivo. Kivo makes the logistical and administrative aspects of my job easy, especially because it has been so easy for my non-regulatory colleagues to learn and use. I wholeheartedly recommend the Kivo system to any pharmaceutical company looking for ways to get organized and manage quality compliance. With all that Kivo has to offer, I can't imagine using anything else. **What do you dislike about Kivo?** Honestly I am struggling to think of the downsides of Kivo. Anything that I would have considered to be missing in the past (e.g., eCTD viewer or project management features) has now been added to the system. Looking forward to see what comes next! **What problems is Kivo solving and how is that benefiting you?** When I started working at my current company, all of our documents were in SharePoint, scattered across too many folders and with multiple versions and/or duplicate copies of the same document in various places. Needless to say, getting up to speed on a drug development program (or 15!) when you can barely even find files or know if the file you found is the current version is a nightmare. Thank goodness we were implementing Kivo around the same time I was hired. Kivo helps us get and stay organized, properly manage version control of a document, easily find documents, build regulatory submissions, track correspondence and requests from health authorities, and more. Moreover, with use of Kivo's eCTD templates and collaborative authoring/review, drafting documents has become so much easier - no more wasting time merging 3+ review versions of a document into one and fixing formatting. Now I can focus on the strategy and writing itself. ### 8. Long term user of Kivo **Rating:** 5.0/5.0 stars **Reviewed by:** Aaron B. | Senior Director Business Development, Small-Business (50 or fewer emp.) **Reviewed Date:** July 18, 2024 **What do you like best about Kivo?** My company has used Kivo and it's previous version, Gemstone, for the past 6 years now. The biggest plus for Kivo is it's intuitiveness and ease of use. Having used other document repositories/QMS systems before, there is nothing more simple than Kivo. Plus the customer service is top notch, whether that is help with handling a task or asking for a new feature to be created Kivo is very quick to respond and able to build in your requests to their entire system. My company was so pleased with Kivo that we have now rolled out all their systems, regulatory, quality and clinical, to all our various functions. **What do you dislike about Kivo?** The only downside of Kivo is documents do not automatically get populated into the eTCD viewer after a regulatory submission and you need to do this manually. **What problems is Kivo solving and how is that benefiting you?** I think the biggest problem Kivo is solving is a eTMF/QMS/RIM for the small companies. Most start-ups and mid-size companies are forced to use the big players in this space, like Veeva, and that is not easy to use for such a small company especially when you need to tailor your busienss to the system. Kivo is the exact opposite and they will tailor Kivo to you! ### 9. Senior Manager, Regulatory Affairs **Rating:** 5.0/5.0 stars **Reviewed by:** Brian A. | Senior Manager, Regulatory Affairs , Mid-Market (51-1000 emp.) **Reviewed Date:** July 18, 2024 **What do you like best about Kivo?** Kivo is extremly user friendly, which has allowed implementation of the RIM system seamless throughout our company. The Kivo team has been great in walking us through the various questions we have and implementing feedback to better enhance our experience. As we shifted away from SharePoint and to Kivo we though the integration process across the company would be dificult, but so far we have had company buy-in and recieved great feedback. **What do you dislike about Kivo?** During review periods or "collaborations" it would be great if the "@" system would work, this makes it easier for collaborators to call out the most relevant individuals. We have yet to fully go through our IND, but thus far this is my takeaway. **What problems is Kivo solving and how is that benefiting you?** We did not have a proper RIM system at our company. We are growing as a company and having things in multiple places is beggining to become a problem. Moving into Kivo we can expect all our documents to be located in one, controlled location. ### 10. Right-sized document management, submission staging, and project management tool **Rating:** 5.0/5.0 stars **Reviewed by:** Lisa V. | Chief Operating Officer and Vice President, R&D, Small-Business (50 or fewer emp.) **Reviewed Date:** August 14, 2024 **What do you like best about Kivo?** 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. **What do you dislike about Kivo?** There's nothing about it that is problematic for me. **What problems is Kivo solving and how is that benefiting you?** Content creation, document storage and archiving, submission staging, project management ### 11. Best system! **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Pharmaceuticals | Mid-Market (51-1000 emp.) **Reviewed Date:** August 02, 2024 **What do you like best about Kivo?** Built for the regulatory professional. Compared to other systems I've used, Kivo is more intuitive and customizable. The EDMS functionality is very efficient and the customer support is above and beyond. The new platform for project management has the potential to be a game changer for regulatory submission timelines/document management. **What do you dislike about Kivo?** The first time we used the collaborative review feature, it was not immediately clear how to best utilize the versioning function, but luckily Kivo provides lightning fast support and was able to advise us until we got the hang of it. The collaborative review versioning is slightly different than other systems I've used, but once you get the hang of it it's far better than others. **What problems is Kivo solving and how is that benefiting you?** Having the collaboration tool and EDMS in one, that is then further linked to a submission builder (with an integrated eCTD viewer!) is extremely efficient and clever. The project planning tool takes it a step further, so really everything I need to plan a submission is in one system. ### 12. Excellent eQMS solution with outstanding customer support **Rating:** 5.0/5.0 stars **Reviewed by:** Nathan R. | Vice President of Product, Small-Business (50 or fewer emp.) **Reviewed Date:** August 14, 2024 **What do you like best about Kivo?** Kivo provided exceptional customer support during our implementation process. They offered quick turnaround times and custom assistance to help us rapidly enhance our compliance efforts. Their professionalism and expertise significantly raised our confidence in achieving optimized compliance for our organization. **What do you dislike about Kivo?** I honestly can't say there has been anything that I can point to that we've had any issues or dislikes with the product or support. **What problems is Kivo solving and how is that benefiting you?** They are serving as our eQMS system for regulartory compliance for our clinical trial solution as well as our eTMF ### 13. Simple and easy **Rating:** 5.0/5.0 stars **Reviewed by:** Sol R. | Sr Director of Program Leadership & Business Development, Small-Business (50 or fewer emp.) **Reviewed Date:** August 14, 2024 **What do you like best about Kivo?** Simplicity of documentation is best. No onerous additional processes. Easily customizable. We are a small company and appreciated the Kivo team's help in getting us set up fast and their support in customizing. **What do you dislike about Kivo?** Admittedly, we have not yet used it enough to say what we dislike the most. We will keep the Kivo team up-to-date as we learn. **What problems is Kivo solving and how is that benefiting you?** Organizing our files to more seemlessly submit an IND. ### 14. Perfect for Fulcrum Therapeutics **Rating:** 5.0/5.0 stars **Reviewed by:** ben d. | Manager, Regulatory Affairs Operations, Mid-Market (51-1000 emp.) **Reviewed Date:** June 26, 2024 **What do you like best about Kivo?** Implementation + Integration was a breeze. Super easy to use and effortless to make changes once live, and no in-house validation required. Strong customer support. Great practical features. **What do you dislike about Kivo?** Not as robust as some of the larger comapnies. **What problems is Kivo solving and how is that benefiting you?** Kivo supports regulatory filings by centralizing data, managing documents, and tracking submission statuses, simplifying the process for regulatory teams to stay compliant and efficient. Workflows are easy. ### 15. Great Company, Attention to Detail, Always there to help **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Biotechnology | Small-Business (50 or fewer emp.) **Reviewed Date:** August 14, 2024 **What do you like best about Kivo?** Easy to use software that makes editing, reviewing, and approving documents a breeze. Great for small companies. TMF and eCTD features have been very helpful in organizing our trials and submissions. **What do you dislike about Kivo?** Some learning involved to get used to the software, but this is not difficult. **What problems is Kivo solving and how is that benefiting you?** We needed a place to store documents, set up document flows, and organize both our clinical trial essential documents and our regulatory submissions. They made it easy and straight forward. ### 16. Built by User Community **Rating:** 4.5/5.0 stars **Reviewed by:** Marion M. | Principle Consultant, Mid-Market (51-1000 emp.) **Reviewed Date:** August 13, 2024 **What do you like best about Kivo?** How easy it is to get started and use the system **What do you dislike about Kivo?** The navigation on the left side can be confusing **What problems is Kivo solving and how is that benefiting you?** Regulatory compliance of managing clinical trial content. The QMS features are also very helpful in maintaining compliance. ### 17. We have had an amazing experience with the product and the team. **Rating:** 5.0/5.0 stars **Reviewed by:** Terry P. | CEO & Founder, Small-Business (50 or fewer emp.) **Reviewed Date:** August 14, 2024 **What do you like best about Kivo?** Its ease of use and interface along with implementation and features really make it an amazing product. I also feel the team is excellent and very responsive. **What do you dislike about Kivo?** There is not much we are very happy with the product. **What problems is Kivo solving and how is that benefiting you?** We are trying to bring down our travel spend and book of record. ### 18. Enabled Streamlined TMF Management and Oversight **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Biotechnology | Mid-Market (51-1000 emp.) **Reviewed Date:** June 07, 2024 **What do you like best about Kivo?** Kivo was easy to implement and our organization was able to onboard our team into the system very quickly. The Kivo TMF structure is intuitive and easy to use to enable efficient uploading, review and QC of study documents. The Kivo Team is very easy to work with and always willing to work with our team. **What do you dislike about Kivo?** Kivo is still an evolving platform so some of the features are still being developed. **What problems is Kivo solving and how is that benefiting you?** Kivo has allowed our team to consolidate several TMFs archived across many CROs - leading to improved oversight of documentation and significant cost savings. ### 19. Great platform for small businesses **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Pharmaceuticals | Small-Business (50 or fewer emp.) **Reviewed Date:** August 14, 2024 **What do you like best about Kivo?** Customer service has been great. The platform offers many of the bells and whistles that other platforms offer, but at a reasonable price. **What do you dislike about Kivo?** So far, no challenges working with the platform. **What problems is Kivo solving and how is that benefiting you?** Kivo is keeping all of our TMF documents in a compliant and easy-to-use system. ### 20. Seamless Interaction **Rating:** 5.0/5.0 stars **Reviewed by:** Amanda M. | Small-Business (50 or fewer emp.) **Reviewed Date:** August 31, 2023 **What do you like best about Kivo?** The ease of use and the ease of interacting with parties involved in the process. **What do you dislike about Kivo?** There is nothing that I dislike about Kivo. **What problems is Kivo solving and how is that benefiting you?** Submitting confidential documents to our consultants to compile and submit to the FDA. - [View Kivo pricing details and edition comparison](https://www.g2.com/products/kivo/reviews?qs=pros-and-cons§ion=pricing&secure%5Bexpires_at%5D=2026-05-14+17%3A46%3A28+-0500&secure%5Bsession_id%5D=3b3a7828-e471-44f6-b831-17d974bfcc9b&secure%5Btoken%5D=70d596bac7d7d3e44d6d81a2790b9a879bc2d798d75f532d59c6a9511a1530c2&format=llm_user) ## Kivo Features **Sales** - Account Management - Sales Coaching **Quality Management** - Design Controls - Audit Management - Supplier Network Management - Risk Management **Content Management** - Bulk Upload and Indexing - Document Tracking - Version Controlling - Search Engine - File Planning and Milestones - Real-Time Authoring and Collaboration - Content Workflows **Document Management** - Dossier Management - Tech Files - Submission Planning - Archiving **Operations** - Field Operations Management - Data Management - Multichannel Engagement - Task Automation - Industry Regulations **Quality System** - Analytics & Reporting - Real-time Collaboration - Document Control - Quality Processes **Regulatory Compliance** - Dashboards and Reporting - TMF Reference Models - Inspection Readiness - Role Permissions **Product Management** - Audit Trails - Live Dashboards - Collaborative Authoring **Activity Management** - Product-To-Market Management - Regulatory Adherence - Information Management - Process Automation - Sales Management **Regulatory Affairs** - Automated Notifications - Communication Tools ## Top Kivo Alternatives - [Egnyte](https://www.g2.com/products/egnyte/reviews) - 4.5/5.0 (1,130 reviews) - [Qualio](https://www.g2.com/products/qualio/reviews) - 4.4/5.0 (730 reviews) - [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) - 4.3/5.0 (504 reviews)