---
title: "RegDocs365 Software Reviews, Demo & Pricing - 2026"
description: "Review of RegDocs365 Software: system overview, features, price and cost information. Get free demos and compare to similar programs."
source_url: "https://www.softwareadvice.com/clinical-trial-management/regdocs365-profile/"
page_type: "product"
language: "en"
---

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RegDocs365

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Overview

[Reviews](https://www.softwareadvice.com/clinical-trial-management/regdocs365-profile/reviews/)

# RegDocs365 Review

From $100/month 1 plan

Wondering if RegDocs365 is right for your organization?

Our Document Management Software selection experts can help you in 15 minutes or less.

On this page

-   Overview
    
-   User Interface
    
-   Popular Alternatives
    
-   Pricing and Plans
    
-   Features
    
-   Integrations
    
-   User Reviews
    

## Overview

RegDocs365

3.9

[(19)](https://www.softwareadvice.com/clinical-trial-management/regdocs365-profile/reviews/)

Pricing

Starting at $100.00 flat rate per month

### About RegDocs365

RegDocs365 is an electronic regulatory document management (EDM) system for life sciences. It caters to biotech, pharmaceutical, and medical device companies. The platform offers core features for managing regulatory documents. It provides a centralized repository for documents like FDA 1572 forms, protocols, and SOPs. The system has robust search capabilities to find documents quickly.

Additionally, it also enables version control and audit trails to track document changes. RegDocs365 also allows for secure collaboration between internal and external users. For deployment, RegDocs365 is a cloud-based system accessed via any standard web browser. Ongoing support is provided through an expert customer service team available via phone, email, and chat.

Do you work for RegDocs365? [Manage this product listing](https://www.g2.com/products/regdocs365/claim_requests/new?auto=true)

Wondering if RegDocs365 is right for your organization?

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## RegDocs365 User Interface

## Popular RegDocs365 Alternatives

Main Product

RegDocs365

3.9

[(19)](https://www.softwareadvice.com/clinical-trial-management/regdocs365-profile/reviews/)

Ratings Breakdown

-   3.79Ease of use
-   3.89Value for money
-   4.08Customer support
-   3.79Functionality

Pricing

Starting at $100.00 per month

Get Price

Alternative Product

[Florence eBinders](https://www.softwareadvice.com/clinical-trial-management/ebinders-profile/)

4.5

[(83)](https://www.softwareadvice.com/clinical-trial-management/ebinders-profile/reviews/)

Ratings Breakdown

-   4.19Ease of use
-   4.52Value for money
-   4.58Customer support
-   4.36Functionality

Pricing

Available upon request

Get Price

Alternative Product

[Clinion EDC](https://www.softwareadvice.com/electronic-data-capture/clinion-edc-profile/)

4.8

[(59)](https://www.softwareadvice.com/electronic-data-capture/clinion-edc-profile/reviews/)

Ratings Breakdown

-   4.81Ease of use
-   4.81Value for money
-   4.81Customer support
-   4.75Functionality

Pricing

Starting at $1000.00 per month

Get Price

Alternative Product

[ResearchManager](https://www.softwareadvice.com/clinical-trial-management/research-manager-profile/)

4.2

[(118)](https://www.softwareadvice.com/clinical-trial-management/research-manager-profile/reviews/)

Ratings Breakdown

-   4.0Ease of use
-   4.07Value for money
-   3.99Customer support
-   3.98Functionality

Pricing

Available upon request

Get Price

Alternative Product

[EDGE](https://www.softwareadvice.com/product/220291-EDGE/)

4.9

[(48)](https://www.softwareadvice.com/product/220291-EDGE/reviews/)

Ratings Breakdown

-   4.90Ease of use
-   4.84Value for money
-   4.93Customer support
-   4.58Functionality

Pricing

Starting at £1000.00 per year

Get Price

Alternative Product

[Castor EDC](https://www.softwareadvice.com/data-collection/castor-edc-profile/)

4.7

[(204)](https://www.softwareadvice.com/data-collection/castor-edc-profile/reviews/)

Ratings Breakdown

-   4.70Ease of use
-   4.59Value for money
-   4.74Customer support
-   4.49Functionality

Pricing

Available upon request

Get Price

## RegDocs365 Pricing and Plans

Starting price: $100.00 per month

Free Trial

Free Version

Basic

$100.00

flat rate, per month

No plan information available

Confused about pricing? We've got you covered.

Get a personalized pricing breakdown tailored to your specific needs—no guesswork, no generic estimates.

## RegDocs365 Features

-   Popular features found in Document Management
    
    Access Controls/Permissions
    
    Archiving & Retention
    
    Collaboration Tools
    
    Compliance Tracking
    
    Document Classification
    
    Document Editing
    
    Document Generation
    
    Electronic Signature
    
    File Conversion
    
    File Sharing
    
    Third-Party Integrations
    
    Version Control
    
-   More features of RegDocs365
    
    21 CFR Part 11 Compliance
    
    Activity Tracking
    
    Alerts/Notifications
    
    Audit Trail
    
    Clinical Study Management
    
    Compliance Management
    
    Customizable Reports
    
    Data Capture and Transfer
    
    Data Import/Export
    
    Data Verification
    
    Digital Signature
    
    Document Management
    
    Document Storage
    
    Double Data Entry
    
    Drag & Drop
    
    Electronic Data Capture
    
    Forms Management
    
    HIPAA Compliant
    
    Real-Time Data
    
    Real-Time Reporting
    
    Workflow Management
    

## RegDocs365 Integrations

Microsoft SharePoint

Integration rated undefined from -1 review

AWS AppSync

Integration rated undefined from -1 review

## RegDocs365 User Reviews

## RegDocs365 customer ratings

- Overall rating: 3.9/5
- Total reviews: 19

### Rating distribution

- 5 stars: 5 reviews (26%)
- 4 stars: 9 reviews (47%)
- 3 stars: 4 reviews (21%)
- 2 stars: 0 reviews (0%)
- 1 star: 1 reviews (5%)

### Secondary ratings

- Ease of use: 3.8/5
- Value for money: 3.9/5
- Customer support: 4.1/5
- Functionality: 3.8/5

---

### Simple and Reliable Compliance Document Management Tool

- Overall rating: 5/5
- Reviewer: Nikole R.
- Verified reviewer: Yes
- Industry: Accounting
- Company size: 2-10 employees
- Product usage: Used daily for more than 2 years
- Reviewed: May 2026
- Review source details: This review was submitted organically. No incentive was offered

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.

#### Ratings breakdown

- Ease of use: 5/5
- Value for money: 5/5
- Customer support: 5/5
- Functionality: 5/5

#### 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.

#### 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.

---

### Chief Operating Officer and SVP Research and Development

- Overall rating: 4/5
- Reviewer: Kelvin C.
- Verified reviewer: Yes
- Industry: Pharmaceuticals
- Company size: 2-10 employees
- Product usage: Used daily for less than 2 years
- Reviewed: September 2024
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

Overall very positive experience storing and locating files to ensure secure storage and compliance with regulations

#### Ratings breakdown

- Ease of use: 4/5
- Value for money: 5/5
- Customer support: 3/5
- Functionality: 4/5

#### 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

---

### Not yet perfect

- Overall rating: 3/5
- Reviewer: Thomas L.
- Verified reviewer: Yes
- Industry: Pharmaceuticals
- Company size: 1001-5000 employees
- Product usage: Used weekly for less than 12 months
- Reviewed: September 2024
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

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.

#### Ratings breakdown

- Ease of use: 3/5
- Value for money: 3/5
- Customer support: 3/5
- Functionality: 2/5

#### 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.

---

### RegDocs 365

- Overall rating: 4/5
- Reviewer: Sarah S.
- Verified reviewer: Yes
- Industry: Research
- Company size: 51-200 employees
- Product usage: Used weekly for more than 2 years
- Reviewed: July 2020
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

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.

#### Ratings breakdown

- Ease of use: 4/5
- Customer support: 5/5
- Functionality: 3/5

#### 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.

#### Vendor response

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.

Replied September 2020

---

### Good if used consistently

- Overall rating: 4/5
- Reviewer: Carol M.
- Verified reviewer: Yes
- Industry: Pharmaceuticals
- Company size: 2-10 employees
- Product usage: Used monthly for more than 2 years
- Reviewed: September 2024
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

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

#### Ratings breakdown

- Ease of use: 4/5
- Value for money: 4/5
- Customer support: 4/5
- Functionality: 4/5

#### Pros

A good repository for sharing clinical trial related documentation

#### Cons

Password update seems to be slightly more complicated than it need be

---

### Honest Review

- Overall rating: 1/5
- Reviewer: Daniel V.
- Verified reviewer: Yes
- Industry: Research
- Company size: 10000+ employees
- Product usage: Used other for more than 2 years
- Reviewed: July 2020
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

#### Ratings breakdown

- Ease of use: 1/5
- Customer support: 2/5
- Functionality: 1/5

#### 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.

#### Vendor response

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.

Replied September 2020

---

### it is an advanced planning and scheduling software.

- Overall rating: 4/5
- Reviewer: sanu k.
- Verified reviewer: Yes
- Industry: Education Management
- Company size: 1001-5000 employees
- Product usage: Used weekly for less than 12 months
- Reviewed: January 2023
- Review source details: This review was submitted organically. No incentive was offered

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

#### Ratings breakdown

- Ease of use: 5/5
- Value for money: 4/5
- Customer support: 5/5
- Functionality: 4/5

#### 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

---

### Good system to manage documents

- Overall rating: 4/5
- Reviewer: Shuai L.
- Verified reviewer: Yes
- Industry: Biotechnology
- Company size: 501-1000 employees
- Product usage: Used weekly for more than 2 years
- Reviewed: July 2020
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

#### Ratings breakdown

- Ease of use: 4/5
- Functionality: 4/5

#### 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.

#### Vendor response

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.

Replied September 2020

---

### Site Overview of System

- Overall rating: 4/5
- Reviewer: Bertina W.
- Verified reviewer: Yes
- Industry: Research
- Company size: 11-50 employees
- Product usage: Used daily for less than 12 months
- Reviewed: July 2020
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

would like a smoother system

#### Ratings breakdown

- Ease of use: 4/5
- Value for money: 3/5
- Customer support: 4/5
- Functionality: 4/5

#### Pros

Able to download documents and go back and correct them

#### Cons

Long process it is complicate to get use to system

#### Vendor response

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.

Replied September 2020

---

### Not bad, not too bad at all

- Overall rating: 5/5
- Reviewer: Diana S.
- Verified reviewer: Yes
- Industry: Research
- Company size: 51-200 employees
- Product usage: Used other for less than 2 years
- Reviewed: August 2020
- Review source details: This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.

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..

#### Ratings breakdown

- Ease of use: 5/5
- Customer support: 5/5
- Functionality: 4/5

#### 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.

#### Vendor response

Great to hear and we would love to hear about what we could add to make your file even easier.

Replied September 2020

---

Showing 1 - 10 of 19 Reviews

[See All Reviews](https://www.softwareadvice.com/clinical-trial-management/regdocs365-profile/reviews/)

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