What is RegDocs365?

A comprehensive, adaptable, and real-time collaborative solution designed for Clinical Research Organizations, Life Science Advisors, and other industry participants is available seamlessly. This system is constructed within an Audit Ready Compliant Cloud (ARCC) environment, ensuring compliance with all 21 CFR Part 11 standards and GxP audit readiness. It features pre-configured departmental setups that facilitate communication with both internal and external stakeholders, enabling secure data integration for remote teams. The platform supports collaborative review and approval processes, allowing access to be toggled based on necessity (such as during audits), which significantly decreases audit preparation time from several days to mere hours. Additionally, it comes ready to align with eTMF Reference models and EDM, while intelligent content management capabilities enhance workflow efficiency. With real-time collaboration, automatic indexing, and co-authoring functionalities, document management becomes more streamlined. This validated system is specifically designed to handle documents and data electronically, adhering to eCTD regulations, thereby ensuring that all stakeholders can operate effectively and efficiently. By embracing this technology, organizations can transform the way they manage and share vital documents in the life sciences sector.

Pricing

Price Overview:
Per user, Per month

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Company Facts

Company Name:
Court Square Group
Date Founded:
1995
Company Location:
United States
Company Website:
www.regdocs365.com
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Product Details

Deployment
SaaS
Training Options
Documentation Hub
Online Training
On-Site Training
Support
Standard Support
24 Hour Support

Product Details

Target Company Sizes
Individual
1-10
11-50
51-200
201-500
501-1000
1001-5000
5001-10000
10001+
Target Organization Types
Mid Size Business
Small Business
Enterprise
Freelance
Nonprofit
Government
Startup
Supported Languages
English

RegDocs365 Categories and Features

Document Management Software

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Document Control Software

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Clinical Trial Management Software

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

More RegDocs365 Categories