Audience

Pharmaceutical, biotech, life science, medical device vendors, and more

About RegDocs365

Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.

Pricing

Pricing Details:
Per user, Per month

Integrations

Ratings/Reviews

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ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Company Information

Court Square Group
Founded: 1995
United States
www.regdocs365.com

Videos and Screen Captures

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Product Details

Platforms Supported
Cloud
Training
Documentation
Live Online
In Person
Support
Phone Support
24/7 Live Support

RegDocs365 Frequently Asked Questions

Q: What kinds of users and organization types does RegDocs365 work with?
Q: What languages does RegDocs365 support in their product?
Q: What kind of support options does RegDocs365 offer?
Q: What other applications or services does RegDocs365 integrate with?
Q: What type of training does RegDocs365 provide?
Q: What pricing for support is available for RegDocs365?

RegDocs365 Product Features

Clinical Trial Management

21 CFR Part 11 Compliance Supported
Document Management Supported
Electronic Data Capture Supported
HIPAA Compliant Supported
Enrollment Management Not Supported
Monitoring Not Supported
Patient Database Not Supported
Recruiting Management Not Supported
Scheduling Not Supported
Study Planning Not Supported

Document Control

Change Management Not Supported
Escalation Management Not Supported
Periodic Review Not Supported
Compliance Management Not Supported
Archiving & Retention Not Supported
Automated Routing Not Supported
Electronic Signature Not Supported
Version Control Not Supported

Document Management

Electronic Signature Not Supported
Email Management Not Supported
Print Management Not Supported
Access Controls Not Supported
Version Control Not Supported
Document Conversion Not Supported
Archiving & Retention Not Supported
Document Delivery Not Supported
Full Text Search Not Supported
Document Indexing Not Supported
Document Assembly Not Supported
Forms Management Not Supported
File Type Conversion Not Supported
Offline Access Not Supported
Collaboration Tools Not Supported
Document Archiving Not Supported
File Recovery Not Supported
Document Retention Not Supported
Optical Character Recognition Not Supported
Compliance Tracking Not Supported
Document Capture Not Supported

RegDocs365 Additional Categories