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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 Elyse?

Elyse® is a high-integrity controlled document management system. Designed from the ground up to serve the people who use it, Elyse has a User-Centric data architecture that carefully mirrors the real world experience of how users expect controlled document management systems to behave. The result is: Users find what they need faster and experience less frustration. Administrators spend less time maintaining the system because there are fewer workarounds and customizations. Auditors have stronger evidence because foundational rules are hard wired. Organizations have a platform that is easier to validate and extend because it doesn't need program code to compensate for highly abstracted data. The protection of your data is ensured through fully ACID-compliant storage, accompanied by an advanced security framework. This system incorporates role-based access control and comprehensive data permissions, making it ideal for large-scale enterprises. Additionally, the unique document identifier namespace guarantees that all document IDs are distinct from the very beginning, while its format-agnostic nature allows for seamless migration from older systems. For organizations deploying in multi-user production settings, the licensing model is designed to be straightforward, providing a trust-based perpetual license for each database instance without imposing any ongoing subscription or upgrade costs. In contrast, the platform remains free for individual users or non-production purposes, offering full functionality. Elyse is designed for any organization that needs to manage controlled documents such as procedures, standards, SOPs, work instructions, quality plans, manuals and engineering drawings. It is fully configured and ready to use out of the box and does not require a team of deployment specialists.

Media

Media

Integrations Supported

Crow Canyon Contract Management

Integrations Supported

API Availability

API Availability

Pricing Information

Per user, Per month

Pricing Information

$3,500
For multi-user production environment deployment the license is a low friction trust-based per-database instance perpetual license. There are no recurring subscriptions or upgrade fees. For single user or non-production use the product is free and fully featured.
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

Windows
On-Prem

Customer Service / Support

Standard Support
24 Hour Support

Customer Service / Support

Not specified

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

Silkwood Software

Date Founded

2009

Company Location

Australia

Company Website

silkwoodsoftware.com

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

Archiving & Retention
Compliance Management
Periodic Review
Version Control

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