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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 Comala Document Control?

Employ either simple approval methods or more advanced workflows to assign approvers for your documents, ensuring that each item receives comprehensive review and approval. When combined with our Quality Management System workflow, these approvals can include electronic signatures, enhancing overall efficiency. Furthermore, the read confirmations feature permits the allocation of specific pages for user review, allowing for the tracking of their acknowledgments. The Appfire platform offers a wide range of popular applications designed to help teams worldwide address significant challenges effectively. You can select from three unique workflows created by Comalatech, making it easy to manage both approved documents and those that are still pending approval. For those seeking more adaptability in their approval processes, Comala Document Management allows for limitless, fully customizable approval workflows tailored to meet specific requirements. To avoid any technical issues, it is recommended not to install this app on the same server as Comala Document Management or Comala Document Approval, ensuring a smoother operational experience for all users. By implementing these strategies, organizations can optimize their document management processes while upholding stringent quality standards. Ultimately, this approach not only enhances efficiency but also fosters a culture of continuous improvement within the organization.

Media

Media

Integrations Supported

Crow Canyon Contract Management

Integrations Supported

Confluence

API Availability

API Availability

Pricing Information

Per user, Per month

Pricing Information

$3,600 per year

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

Court Square Group

Date Founded

1995

Company Location

United States

Company Website

www.regdocs365.com

Company Facts

Organization Name

Comalatech

Date Founded

2005

Company Location

Canada

Company Website

marketplace.atlassian.com/apps/1215729/comala-document-control

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
HIPAA Compliant

Document Control

Not specified

Document Management

Not specified

Categories and Features

Document Control

Not specified

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