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Kivo Reviews & Product Details

D
Manager, Regulatory Affairs Operations
Mid-Market(51-1000 emp.)
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Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

What do you dislike about Kivo?

Not as robust as some of the larger comapnies. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

Kivo Overview

What is Kivo?

Kivo is the easiest-to-use document and regulatory management solution for life science companies. Kivo's platform includes DMS, RIM, QMS, eTMF and more. All features are included with your subscription - with no separate charges or hidden fees. CFR Part 11 Compliant e-Sign with Docusign | Lifetime Validation | 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 more • 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 Details
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Kivo Community
Languages Supported
English
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Product Description

Kivo makes simple and affordable document management systems including RIM, eTMF, and QMS. A single license grants access to all our solutions, so you can supercharge cross-functional collaboration without breaking the bank. Fully validated, Part 11 and SOC 2 compliant, Kivo is designed forGxP.


Seller Details
Seller
Kivo
Year Founded
2021
HQ Location
Portland, US
LinkedIn® Page
www.linkedin.com
21 employees on LinkedIn®

Jianna L.
JL
Overview Provided by:

Recent Kivo Reviews

LV
Lisa V.Small-Business (50 or fewer emp.)
5.0 out of 5
"Right-sized document management, submission staging, and project management tool"
Kivo is a great tool for small organizations to store both business as well as regulatory documents. The system is user friendly and minimal train...
Ken V.
KV
Ken V.Small-Business (50 or fewer emp.)
5.0 out of 5
"Great product with the right cost/complexity point"
Kivo is a "right sized" tool that allows a life sciences company to establish and maintain compliance with regulated documentation practices withou...
Verified User
U
Verified UserSmall-Business (50 or fewer emp.)
5.0 out of 5
"Great Company, Attention to Detail, Always there to help"
Easy to use software that makes editing, reviewing, and approving documents a breeze. Great for small companies. TMF and eCTD features have been ...
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Kivo Media

Kivo Demo - Hi, We're Kivo
Kivo offers a shared workspace where every function can manage their documents, programs and even vendors in a way that's intuitive, efficient and - of course - compliant. And our all-inclusive pricing means that everyone has access, without breaking the bank.
Kivo Demo - Kivo Dashboard
See the status of your documents, placeholders, and collaborations at a glance on the Kivo dashboard.
Kivo Demo - Kivo RIM
Say goodbye to version control issues with Kivo’s submission management workflows. Compliance focused user permissions and access controls help build your audit trail automatically. Centralized document storage is aligned to the Electronic Document Management (EDM) reference model. Import, view, ...
Kivo Demo - Kivo eTMF
Kivo's eTMF is built on the TMF reference model. With advanced reporting and analytics, you can verify your TMF completeness at a glance. And with built in workflows and process management tools designed to follow all relevant regulations, you can enforce compliance across all your contributors.
Kivo Demo - Kivo QMS
Control your documents, run audits and CAPAs, manage vendors, and keep track of trainings with Kivo's Quality Management Software.
Answer a few questions to help the Kivo community
Have you used Kivo before?
Yes

14 out of 15 Total Reviews for Kivo

5.0 out of 5
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14 out of 15 Total Reviews for Kivo
5.0 out of 5
14 out of 15 Total Reviews for Kivo
5.0 out of 5

Kivo Pros and Cons

How are these determined?Information
Pros and Cons are compiled from review feedback and grouped into themes to provide an easy-to-understand summary of user reviews.
Pros
Cons

Overall Review Sentiment for KivoQuestion

Time to Implement
<1 day
>12 months
Return on Investment
<6 months
48+ months
Ease of Setup
0 (Difficult)
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Ken V.
KV
CEO
Small-Business(50 or fewer emp.)
More Options
Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

MB
Senior Manager of Regulatory Strategy
Small-Business(50 or fewer emp.)
More Options
Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

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! Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

AB
Senior Director Business Development
Small-Business(50 or fewer emp.)
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Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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! Review collected by and hosted on G2.com.

Brian A.
BA
Senior Manager, Regulatory Affairs
Mid-Market(51-1000 emp.)
More Options
Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

LV
Chief Operating Officer and Vice President, R&D
Small-Business(50 or fewer emp.)
More Options
Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

What do you dislike about Kivo?

There's nothing about it that is problematic for me. Review collected by and hosted on G2.com.

What problems is Kivo solving and how is that benefiting you?

Content creation, document storage and archiving, submission staging, project management Review collected by and hosted on G2.com.

Verified User in Pharmaceuticals
AP
Mid-Market(51-1000 emp.)
More Options
Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

Nathan R.
NR
Vice President of Product
Small-Business(50 or fewer emp.)
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Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

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 Review collected by and hosted on G2.com.

SR
Sr Director of Program Leadership & Business Development
Small-Business(50 or fewer emp.)
More Options
Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

What problems is Kivo solving and how is that benefiting you?

Organizing our files to more seemlessly submit an IND. Review collected by and hosted on G2.com.

Verified User in Biotechnology
UB
Small-Business(50 or fewer emp.)
More Options
Validated Reviewer
Verified Current User
Review source: Organic
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. Review collected by and hosted on G2.com.

What do you dislike about Kivo?

Some learning involved to get used to the software, but this is not difficult. Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.

MM
Principle Consultant
Mid-Market(51-1000 emp.)
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Validated Reviewer
Verified Current User
Review source: Organic
What do you like best about Kivo?

How easy it is to get started and use the system Review collected by and hosted on G2.com.

What do you dislike about Kivo?

The navigation on the left side can be confusing Review collected by and hosted on G2.com.

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. Review collected by and hosted on G2.com.