# RegDocs365 Software Reviews, Demo & Pricing - 2026

> Review of RegDocs365 Software: system overview, features, price and cost information. Get free demos and compare to similar programs.

Source: https://www.softwareadvice.com/clinical-trial-management/regdocs365-profile

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RegDocs365

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Overview

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

# RegDocs365 2026: Benefits, Features & Pricing

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 per month

Top Alternatives

### 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.

## 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

Alternative Product

[ShareCRF](https://www.softwareadvice.com/clinical-trial-management/sharecrf-profile/)

4.8

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

Ratings Breakdown

-   4.84Ease of use
-   4.60Value for money
-   4.79Customer support
-   4.64Functionality

Pricing

Available upon request

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

Alternative Product

[Researchmanager – Clinical Research Suite](https://www.softwareadvice.com/clinical-trial-management/research-manager-profile/)

4.2

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

Ratings Breakdown

-   3.98Ease of use
-   4.03Value for money
-   4.0Customer support
-   3.99Functionality

Pricing

Available upon request

Alternative Product

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

4.9

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

Ratings Breakdown

-   4.91Ease of use
-   4.85Value for money
-   4.94Customer support
-   4.49Functionality

Pricing

Starting at £1000.00 per year

Alternative Product

[Health Cloud](https://www.softwareadvice.com/remote-patient-monitoring/salesforce-health-cloud-profile/)

4.5

[(42)](https://www.softwareadvice.com/remote-patient-monitoring/salesforce-health-cloud-profile/#reviews)

Ratings Breakdown

-   4.19Ease of use
-   3.91Value for money
-   4.08Customer support
-   4.36Functionality

Pricing

Starting at $350.00 per month

## 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

## RegDocs365 Features

-   Popular features found in Clinical Trial Management
    
    21 CFR Part 11 Compliance
    
    Data Capture and Transfer
    
    Data Import/Export
    
    Document Management
    
    Electronic Data Capture
    
    Financial Management
    
    Inventory Management
    
    Patient Management
    
    Patient Monitoring
    
    Patient Recruiting
    
    Scheduling
    
    Workflow Management
    
-   More features of RegDocs365
    
    Access Controls/Permissions
    
    Activity Tracking
    
    Alerts/Notifications
    
    Audit Trail
    
    Clinical Study Management
    
    Compliance Management
    
    Customizable Reports
    
    Data Verification
    
    Digital Signature
    
    Document Storage
    
    Double Data Entry
    
    Drag & Drop
    
    Forms Management
    
    HIPAA Compliant
    
    Real-Time Data
    
    Real-Time Reporting
    
    Third-Party Integrations
    

## RegDocs365 Integrations

Microsoft SharePoint

Integration rated undefined from -1 review

Workspace ONE

Integration rated undefined from -1 review

AWS AppSync

Integration rated undefined from -1 review

## RegDocs365 User Reviews

Overall Rating

3.9

Ratings Breakdown

5

26%

4

47%

3

21%

2

0%

1

5%

Secondary Ratings

Ease of Use

3.8

Value for money

3.9

Customer support

4.1

Functionality

3.8

NR

Nikole R.

Verified reviewer

Accounting

2-10 employees

Used daily for more than 2 years

Review source

Reviewed May 2026

Simple and Reliable Compliance Document Management Tool

5

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

5

Ease of use

5

Value for money

5

Customer support

5

Functionality

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.

Read More

KC

Kelvin C.

Verified reviewer

Pharmaceuticals

2-10 employees

Used daily for less than 2 years

Review source

Reviewed September 2024

Chief Operating Officer and SVP Research and Development

4

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

Ratings Breakdown

4

Ease of use

5

Value for money

3

Customer support

4

Functionality

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

Read More

TL

Thomas L.

Verified reviewer

Pharmaceuticals

1001-5000 employees

Used weekly for less than 12 months

Review source

Reviewed September 2024

Not yet perfect

3

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

3

Ease of use

3

Value for money

3

Customer support

2

Functionality

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.

Read More

CM

Carol M.

Verified reviewer

Pharmaceuticals

2-10 employees

Used monthly for more than 2 years

Review source

Reviewed September 2024

Good if used consistently

4

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

4

Ease of use

4

Value for money

4

Customer support

4

Functionality

Pros:

A good repository for sharing clinical trial related documentation

Cons:

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

Read More

KK

Katie K.

Verified reviewer

Research

51-200 employees

Used monthly for less than 6 months

Review source

Reviewed September 2024

LOVE RegDocs365

5

Ratings Breakdown

5

Ease of use

5

Functionality

Pros:

Efficiency, thus increasing productivity.

Cons:

I wish it was the standard utilized overall.

Read More

DV

Daniel V.

Verified reviewer

Research

10000+ employees

Used other for more than 2 years

Review source

Reviewed July 2020

Honest Review

1

Ratings Breakdown

1

Ease of use

2

Customer support

1

Functionality

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

Read More

SS

Sarah S.

Verified reviewer

Research

51-200 employees

Used weekly for more than 2 years

Review source

Reviewed July 2020

RegDocs 365

4

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

4

Ease of use

5

Customer support

3

Functionality

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

Read More

sk

sanu k.

Verified reviewer

Education Management

1001-5000 employees

Used weekly for less than 12 months

Review source

Reviewed January 2023

it is an advanced planning and scheduling software.

4

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

5

Ease of use

4

Value for money

5

Customer support

4

Functionality

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

Read More

SL

Shuai L.

Verified reviewer

Biotechnology

501-1000 employees

Used weekly for more than 2 years

Review source

Reviewed July 2020

Good system to manage documents

4

Ratings Breakdown

4

Ease of use

4

Functionality

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

Read More

VR

Verified

Reviewer

Research

201-500 employees

Used other for less than 12 months

Review source

Reviewed August 2020

still figuring out nuances

3

neutral

Ratings Breakdown

3

Ease of use

3

Functionality

Pros:

Simple interface. Main assignments easy to access

Cons:

few indications on added functionalities

Vendor Response

We would love to hear your suggestions for functionality that you were looking for.

Replied September 2020

Read More

Showing 1 - 10 of 19 Reviews

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