# RegDocs365 Software Pricing, Alternatives & More 2026 | Capterra > With the help of Capterra, learn about RegDocs365 Software - reviews, pricing plans, popular comparisons to other Clinical Trial Management products and more. Source: https://www.capterra.com/p/205888/RegDocs365 --- # RegDocs365 Software Review 2026: Features, Reviews, Integrations, Pros & Cons Last updated on March 13, 2026 Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. Independent research methodology Capterra’s researchers use a mix of verified reviews, independent research and objective methodologies to bring you selection and ranking information you can trust. While we may earn a referral fee when you visit a provider through our links or speak to an advisor, this has no influence on our research or methodology. [Learn more](https://www.capterra.com/resources/proprietary-data-research/) How Capterra verifies reviews Capterra carefully verified over 2.5 million+ reviews to bring you authentic software experiences from real users. Our human moderators verify that reviewers are real people and that reviews are authentic. They use leading tech to analyze text quality and to detect plagiarism and generative AI. [Learn more](https://www.capterra.com/resources/how-we-verify-reviews/) How Capterra ensures transparency Capterra lists all providers across its website—not just those that pay us—so that users can make informed purchase decisions. Capterra is free for users. Software providers pay us for sponsored profiles to receive web traffic and sales opportunities. Sponsored profiles include a link-out icon that takes users to the provider’s website. [Learn more](https://www.capterra.com/resources/how-we-ensure-transparency/) [Description](#description)[Use cases](#use-cases)[Alternatives](#alternatives)[Features](#features)[Pricing](#pricing)[Integrations](#integrations)[Support](#support)[Reviews](#reviews) RegDocs365 ## What is RegDocs365? Regulated Content and Collaboration Solutions for Life Sciences RegDocs365 is a fully 21 CFR Part 11 compliant, ready-to-use, cost-efficient content and document management solution hosted in an Audit Ready Compliant Cloud (ARCC) validated environment. As a turn-key content management solution built specifically for Life Science companies, RegDocs365 supports life science companies actively bringing drugs, biologics, or devices to market in their efforts to prepare regulatory submissions. RegDocs365 provides a Life Science focused platform for all of your workflow, dashboard and document management needs in a fully regulatory compliant fashion. Easily streamline workflows at any stage of development through commercialization, including discovery, clinical trials, regulatory submissions, and post-market. RegDocs365 effectively centralizes and manages all digital content (documents, data, voice, and video) to create, protect, and publish in multi-sponsor environments. ## What is RegDocs365 used for? [Clinical Trial Management](https://www.capterra.com/clinical-trial-management-software/) Top alternative Featured Overall rating Based on 19 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price $100 Flat Rate, Per Month Free trial not available Capterra Shortlist charts the highest-rated and most popular products... Our "Best of" badge program showcases products with the highest ratings... Our "Best of" badge program showcases products with the highest ratings... Do you work for RegDocs365?[Manage this product listing](https://digitalmarkets.gartner.com/get-listed/claim-bx?url=https://www.courtsquaregroup.com&name=RegDocs365) ## Compare with a popular alternative Capterra selects software alternatives based on relevant features, verified user reviews and user interactions. Placement may be influenced by client status. ### RegDocs365 3.9 (19) VS. [4.5 (83)](https://www.capterra.com/p/200364/Florence-eBinders/reviews/) Starting Price $100 Flat Rate, Per Month Starting Price Contact vendor Free Trial Free Version Pricing Options Free Trial Free Version Ease Of Use 3.8 (19) Ease Of Use 4.2 (83) Value For Money 3.9 (9) Value For Money 4.5 (50) Customer Service 4.1 (13) Customer Service 4.6 (65) ## RegDocs365 alternatives [4.8 (6)](https://www.capterra.com/p/275503/SiteLink/#reviews) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 100% of reviewers rated it above 4 stars [4.4 (35)](https://www.capterra.com/p/172299/Health-Cloud/#reviews) Starting price $350.00 Per User, Per Month Pricing Options Free Trial Free Version User Rating 91% of reviewers rated it above 4 stars Highest Rated [5.0 (1)](https://www.capterra.com/p/10033108/CTMS/#reviews) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 100% of reviewers rated it above 4 stars [4.7 (204)](https://www.capterra.com/p/143532/Castor-EDC/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 98% of reviewers rated it above 4 stars [View all alternatives](https://www.capterra.com/p/205888/RegDocs365/alternatives/) ## Features Features with the highest number of reviews are displayed first. Those that have no reviews appear next, sorted alphabetically. Data Capture and Transfer 3.3 (3) 133.33% of 3 reviewers that rated this feature as important or highly important Import, collect, and capture data from multiple sources Data Import/Export 3.0 (3) 166.67% of 3 reviewers that rated this feature as important or highly important Import and export data to and from software applications Document Management 3.7 (3) 133.33% of 3 reviewers that rated this feature as important or highly important Store, manage, and track all electronic documents in a centralized location Audit Trail 3.0 (2) 100.00% of 2 reviewers that rated this feature as important or highly important A record of all activities within the system, including user access, changes made, etc. HIPAA Compliant 5.0 (2) 150.00% of 2 reviewers that rated this feature as important or highly important Compliant with HIPAA, which sets standards for sensitive patient data protection 21 CFR Part 11 Compliance 5.0 (1) 200.00% of 1 reviewers that rated this feature as important or highly important Shows that electronic documents are authentic and linked to specific records RegDocs365 23 features Shows that electronic documents are authentic and linked to specific records Define levels of authorization for access to specific files or systems Track and document all activities across devices, networks, and other systems Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges A record of all activities within the system, including user access, changes made, etc. Tools to manage single or multiple clinical studies within a centralized platform Track and manage adherence to policies for any service, product, process, or supplier Alter the layout and content of reports Import, collect, and capture data from multiple sources Import and export data to and from software applications Process of checking different types of data for accuracy to avoid errors or inconsistencies Electronic signing method that validates the authenticity and integrity of a digital document Store, manage, and track all electronic documents in a centralized location Store and organize documents in a centralized system Data entry quality control method that involves recording the same data twice to maintain integrity Assemble applications and processes by dragging over and arranging pre-built components Import, collect, and capture data from multiple sources Store, manage and track all forms in a centralized location Compliant with HIPAA, which sets standards for sensitive patient data protection Receive data and information in real time Active reporting of data and metrics Set up connections to third-party platforms to improve business processes Create, design and manage workflows for repetitive tasks Features 3.8 (19) 3.8 Based on 19 reviews ## Pricing Value for money 3.9 (9) Basic $100.00 Flat Rate,Per Month Value for money 3.9 (9) 3.9 Based on 9 reviews ## Integrations [ Microsoft SharePoint](https://www.capterra.com/p/1167/SharePoint/)[ Workspace ONE](https://www.capterra.com/p/206931/VMware/)[ AWS AppSync](https://www.capterra.com/p/234165/AWS-AppSync/) ## Support, customer service and training options Customer Service 4.1 (13) Support - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - 24/7 (Live rep) - Chat Training - In Person - Live Online - Webinars - Documentation - Videos Deployment - Web - Android - iPhone/iPad Typical users - Freelancers - Small businesses - Mid size businesses - Enterprises Customer Service 4.1 (13) 4.1 Based on 13 reviews ## User reviews Overall rating 3.9 Based on 19 reviews Filter by rating 5(5) 4(9) 3(4) 2(0) 1(1) Mentioned topic Sorted by most recent NR Nikole R. Permit Technician Accounting ### "Simple and Reliable Compliance Document Management Tool" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 May 1, 2026 Overall, RegDocs365 has been a reliable tool for managing compliance documents and records. It helps keep everything organized, secure, and easy to access for audits or reporting. While it isn’t the most flexible system for customization, it performs well for its core purpose of document compliance management. Pros What I like most about RegDocs365 is how it simplifies document compliance and organization. It keeps all required forms, permits, and records in one secure system, making it easy to stay compliant and audit-ready. Cons The main downside is that it can feel a bit limited in customization and integration options compared to larger document management systems. Some workflows also require manual setup, which can take time upfront. Alternatives considered [IMS](https://www.capterra.com/p/12549/MICA-MED/) [Florence eBinders](https://www.capterra.com/p/200364/Florence-eBinders/) [QT9 QMS](https://www.capterra.com/p/97557/QT9-Quality-Management/) Reasons for choosing RegDocs365 We chose RegDocs365 because it’s purpose-built for life sciences and already meets strict compliance requirements like 21 CFR Part 11 out of the box. Compared to other tools, it required less customization and provided stronger built-in workflows, audit readiness, and regulatory-focused document control. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. KK Katie K. Clinical Research Associate Research ### "LOVE RegDocs365" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 0.0 0.0 Likelihood to Recommend 10/10 September 26, 2024 Pros Efficiency, thus increasing productivity. Cons I wish it was the standard utilized overall. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. TL Thomas L. Senior Medical Director Pharmaceuticals ### "Not yet perfect" 3.0 Overall Rating 3.0 3.0 Ease of Use 3.0 3.0 Features 2.0 2.0 Customer Service 3.0 3.0 Likelihood to Recommend 0/10 September 26, 2024 The usual task of forwarding completed documents like Medical Monitoring Plans and DMC Charters is fine, but the Relevant Communications management is a pain point, as noted. Pros I see no advantages of RegDocs365 over the product that my company usually uses (Trial Interactive). Cons With Trial Interactive, I can forward Relevant Communication emails directly to a Communications module that is study-specific, whereas such emails need to be put in PDF form (very awkward if there is an attachment) before submission to RegDocs365. This is hugely inefficient and fixing this would be a big improvement. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. CM Carol M. VP Clinical Operations Pharmaceuticals ### "Good if used consistently" 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 4.0 4.0 Likelihood to Recommend 7/10 September 24, 2024 If used frequently and regularly I think it would be good. As an infrequent user I have to re-aquaint myself with its use each time Pros A good repository for sharing clinical trial related documentation Cons Password update seems to be slightly more complicated than it need be Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. KC Kelvin C. Chief Operating Officer Pharmaceuticals ### "Chief Operating Officer and SVP Research and Development" 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 3.0 3.0 Likelihood to Recommend 10/10 September 17, 2024 Overall very positive experience storing and locating files to ensure secure storage and compliance with regulations Pros Secure 21CFR11 compliant document system Cons Can be clunky to use - drag and drop not allowed between RegDocs365 folders. Login can be challenging sometimes and MSoffice365 security can interfere with RegDocs365 Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. MP Minjun P. Regulatory Affairs Pharmaceuticals ### "Great platform" 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 4.0 4.0 Likelihood to Recommend 6/10 March 27, 2023 Pros It is easy to share files timely among users. Cons It would be great if we could upload and download files more easily. (eg: drag and drop) Also, the interface should be more client-friendly. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. TJ Travis J. Principal Consultant Biotechnology ### "Regdocs365 Works as Intended" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 March 23, 2023 Pros The user friendly interface provides a quick ramp up time for new users. Cons Ocassionally I have found processing to be slower than expected. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor March 28, 2023 Thank you for your feedback. Your input is truly appreciated and heard. If you have any questions or suggestions, we look forward to speaking with you. Please feel free to reach out directly to our support team at info@RegDocs365.com SK sanu k. researcher Education Management ### "it is an advanced planning and scheduling software." 4.0 Overall Rating 4.0 4.0 Ease of Use 5.0 5.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 8/10 January 29, 2023 I have had an overall positive experience with RegDocs365. They have an extensive library of documents and templates that are tailored to specific industries and businesses Pros The most impactful features in RegDocs365 include automated document organization and access, powerful search and filtering capabilities, real-time tracking and audit capabilities, secure virtual data rooms, and an integrated electronic signature platform. Cons Features that could be improved in RegDocs365 include better document searching and filtering capabilities, enhanced collaboration tools, automated workflow tools, and integration with third-party products. Integration with existing business processes could be made easier through built-in features such as data mapping, custom email templates, and automated notifications Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. TP Tania P. Site Services Coordinator Health, Wellness and Fitness ### "Please make it more functional " 4.0 Overall Rating 4.0 4.0 Ease of Use 2.0 2.0 Features 3.0 3.0 Customer Service 4.0 4.0 Likelihood to Recommend 5/10 August 31, 2020 Somehow easy and hard at the same time. Pros Quick in assigning the assignments and easy to access the history part. Cons It is very difficult to update your password. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. AK Andy K. Head. Field Medical Pharmaceuticals ### "not intuitive" 3.0 Overall Rating 3.0 3.0 Ease of Use 2.0 2.0 Features 4.0 4.0 Customer Service 0.0 0.0 Likelihood to Recommend 3/10 August 7, 2020 Pros ability to review and follow through with the admin Cons it is not easy to use and not intuitive. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 It appears you have only been using the training modules. Thank you for taking the extra time to us about a better onboarding process for allowing new users to access the system. DS Diana S. Senior Clinical Research Associate Research ### "Not bad, not too bad at all" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 9/10 August 3, 2020 Overall, RegDocs 365 has been a game changer in that I can view in real-time what is filed and what is not. This is very valuable when collecting documents from a research site. Saves me from duplicating my efforts.. Pros I like being able to review documents which are stored instead of relying on someone else's spreadsheet for information. Cons I have no cons at this point. I mainly use RegDocs365 to review what has already been filed so I can fill in any gaps. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 Great to hear and we would love to hear about what we could add to make your file even easier. AU Anonymous User On demand Clinician Research ### "still figuring out nuances" 3.0 Overall Rating 3.0 3.0 Ease of Use 3.0 3.0 Features 3.0 3.0 Customer Service 0.0 0.0 Likelihood to Recommend 5/10 August 3, 2020 neutral Pros Simple interface. Main assignments easy to access Cons few indications on added functionalities Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 We would love to hear your suggestions for functionality that you were looking for. CA Carmen A. MD training in psychiatry Mental Health Care ### "Amendable" 3.0 Overall Rating 3.0 3.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 0.0 0.0 Likelihood to Recommend 5/10 July 29, 2020 Pros The product is easy to use, user-friendly and knowable Cons I have difficulty logging in if the browser settings are not perfectly correct Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 We welcome the opportunity to work with you to make sure that the browser settings are set optimally for your usage. Please take advantage of our helpdesk to have one of our support engineers to review how we can help configure your browsers. DV Daniel V. Clinical Research Coordinator Research ### "Honest Review" 1.0 Overall Rating 1.0 1.0 Ease of Use 1.0 1.0 Features 1.0 1.0 Customer Service 2.0 2.0 Likelihood to Recommend 0/10 July 29, 2020 Pros I honestly cannot recall anything I liked about using this software. Cons The occasions on which I had to use regdocs365 for work were some my worst experiences with any software in my life thus far. I insisted that the study sponsor which had required us to use regdocs365 instead allow us to use a different method for secure transmission of PHI for review because my use of regdocs35 had been so frustrating and a such a waste of time. I am sure that good people worked to develop this product, but the user experience desperately needs improvement. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 We are very sorry to hear about your frustrations using our software. We have been in the market now for a number of years so it would be advantageous to know if you were using the system recently or in the early days. We've continued to add more functionality to make it easier for our users to enter and report on their documents. We would be very interested in following up with you to see why you had such a bad experience with the system. SS Sarah S. Project Management Associate Research ### "RegDocs 365" 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 3.0 3.0 Customer Service 5.0 5.0 Likelihood to Recommend 9/10 July 29, 2020 RegDocs365 is very responsive when trouble occurs. I have used the system for almost 3 years and changes have been made over the years. I like the way the company takes our feedback seriously and works to improve the system overtime. Pros I love the bulk upload feature and the ease of the folder structures Cons There are times when the system glitches and is slow running; also the checking in and out of documents can be a bit of a nuisance. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 Thanks for your feedback and we are glad to hear that our support staff is responsive to your needs. We continue to add additional capabilities based on suggestions from our users so if you can think of things that you'd like to see incorporated then please submit a helpdesk ticket and we can see about adding that functionality. SL Shuai L. BD Biotechnology ### "Good system to manage documents" 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 0.0 0.0 Likelihood to Recommend 7/10 July 29, 2020 Pros Overall very nice layout. Very easy to find documents due to the very organized and visual structure. Cons Some functions are not very easy to use, e.g. Bulk download will remove all the folder structures. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 Thanks for your feedback and we'd love to follow up with you to understand the specific issue that you ran into as we are sure that we can overcome that particular mechanism. We've also added a number of new features that should enhance the ability to see and report on those documents. BS Brien S. Associate Director Biotechnology ### "Limited USe review" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 0.0 0.0 Likelihood to Recommend 5/10 July 29, 2020 Pros The software seems to be user friendly. Cons I have not used the software enough to identify any issues Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 We welcome your feedback once you've had enough time to feel comfortable to provide that. Please send any suggestions or issues that you may run into to our help desk. BW Bertina W. Sr Research Coordinaor Research ### "Site Overview of System" 4.0 Overall Rating 4.0 4.0 Ease of Use 4.0 4.0 Features 4.0 4.0 Customer Service 4.0 4.0 Likelihood to Recommend 8/10 July 24, 2020 would like a smoother system Pros Able to download documents and go back and correct them Cons Long process it is complicate to get use to system Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 Thanks for your feedback and we would love to speak with you about your experience so that we can provide a more streamlined solution for you. We continuously add new functionality based on user feedback and we strive to enable the easiest system to use. CG cynthia g. Study Coordinator Research ### "Study portal" 4.0 Overall Rating 4.0 4.0 Ease of Use 3.0 3.0 Features 4.0 4.0 Customer Service 4.0 4.0 Likelihood to Recommend 7/10 July 24, 2020 Pros Very easy to uploaded documents needed for the study. Cons It was not user friendly and the password would expire quickly. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. Response from Vendor September 1, 2020 We are sorry to hear about your issues with password expiration as some of those time limits are driven by the sponsors. We would love to hear about why you thought the system wasn't user friendly and how we could do a better job at that. We strive for continuous improvement and we look for user input to help drive our ease of use. If you woudl want to have a quick session with our support staff then we might be able to show you some ways that you may not have thought of using the system. ## Top-rated software of 2026 ### Fill out the form and we'll send a list of the top-rated software based on real user reviews directly to your inbox. Independent research methodology Capterra's researchers use a mix of verified reviews, independent research and objective methodologies to bring you selection and ranking information you can trust. While we may earn a referral fee when you visit a provider through our links or speak to an advisor, this has no influence on our research or methodology. [Learn more](https://www.capterra.com/resources/proprietary-data-research/) How Capterra verifies reviews Capterra carefully verified over 2.5 million+ reviews to bring you authentic software experiences from real users. Our human moderators verify that reviewers are real people and that reviews are authentic. They use leading tech to analyze text quality and to detect plagiarism and generative AI. [Learn more](https://www.capterra.com/resources/how-we-verify-reviews/) How Capterra ensures transparency Capterra lists all providers across its website—not just those that pay us—so that users can make informed purchase decisions. Capterra is free for users. Software providers pay us for sponsored profiles to receive web traffic and sales opportunities. Sponsored profiles include a link-out icon that takes users to the provider's website. [Learn more](https://www.capterra.com/resources/how-we-ensure-transparency/)