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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 Qualis DMS?

The Qualis document management system provides a robust and secure solution for handling documentation, ensuring that users can access regulated and up-to-date materials efficiently. With its workflow-driven document approval process that includes features like revision tracking, users are guaranteed access to the latest approved versions, significantly reducing the risk of using outdated documents. This adaptable workflow can be customized to fit specific roles within the organization, allowing for the implementation of multiple workflows tailored to different types of documents. Additionally, the system promotes sustainability by reducing paper usage and storage requirements while also ensuring the secure storage and easy retrieval of documents. By limiting distribution to only those documents that have received approval, it effectively mitigates the risk associated with disseminating obsolete copies. Moreover, it strengthens regulatory compliance by offering controlled access and facilitating straightforward document searches. All associated metadata is consolidated in a flexible centralized database that is compatible with various systems, such as MS SQL, Oracle, and Postgre SQL. In summary, the Qualis DMS is an all-encompassing solution for document management and distribution within organizations, enhancing both efficiency and compliance throughout the process. Ultimately, this platform not only streamlines document oversight but also fosters greater collaboration among users, ensuring a cohesive approach to managing vital information.

Media

Media

Integrations Supported

Crow Canyon Contract Management

Integrations Supported

Microsoft Excel
Microsoft Word
Oracle SQL Developer
PostgreSQL
SQL Server

API Availability

API Availability

Pricing Information

Per user, Per month

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
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

Agaram

Date Founded

1995

Company Location

India

Company Website

www.agaramtech.com/product/qualis-dms/

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

Document Management

Not specified

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