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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.

What is Nira?

Nira functions as a dynamic access control solution that provides oversight and management of access to corporate documents within Google Workspace. While sharing links facilitates easy collaboration, it often leads to the scattering of company information among various employees, departments, and external parties. This scattering makes access management a complex and challenging task. Conventional offboarding techniques and tools are inadequate, as they do not fully revoke access from personal accounts, allowing external users to retain their access until a comprehensive audit is performed. Identifying and resolving access-related problems often proves to be a complicated endeavor. Nira seamlessly integrates with your cloud applications, delivering a consolidated view of who has access to company data. With Nira at your disposal, you can proficiently manage document access for both internal and external users, gaining real-time insights regarding all documents and their potential risks. Furthermore, it facilitates swift oversight and regulation of vendor access to company files, showcasing how access management can be both straightforward and effective. This increased visibility not only simplifies the process but also guarantees that sensitive information remains protected and accessible solely to authorized personnel, ultimately fostering a culture of security within the organization. By enhancing control over access, Nira empowers organizations to uphold their data integrity and compliance standards.

Media

Media

Integrations Supported

Crow Canyon Contract Management
GitHub
Google Docs
Google Drive
Google Workspace

Integrations Supported

Crow Canyon Contract Management
GitHub
Google Docs
Google Drive
Google Workspace

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Court Square Group

Date Founded

1995

Company Location

United States

Company Website

www.regdocs365.com

Company Facts

Organization Name

Nira

Company Location

United States

Company Website

nira.com

Categories and Features

Clinical Trial Management

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

Document Control

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

Document Management

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

Categories and Features

Document Control

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

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