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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 ACE Essentials?

ACE Essentials serves as an Electronic Quality Management System Software (EQMS) that has been pre-validated for use in industries that are highly regulated. This comprehensive system encompasses ten distinct workflows alongside all necessary Standard Operating Procedures (SOPs) and Policies, guaranteeing that your quality management system is compliant right from the outset. Furthermore, ACE Essentials boasts a complete audit trail that meticulously tracks all actions taken within the system, helping you assess the risks linked to your assets. Key features of ACE Essentials include: - Pre-Configured Workflows - Pre-Configured Event Management (such as Due Dates, Scheduling, and Reminders) - Pre-Configured Permission-Based Security - Pre-Configured Full Documentation comprising over 50 documents - Capability for Multiple Sites - Free Upgrades for the Lifetime of the Product - Pre-Configured Task Lists - No Validation Period Required - Pre-Configured In-System Notifications - Pre-Configured Email Notifications This robust system is designed to streamline quality management practices, ensuring organizations can efficiently meet regulatory demands while focusing on their core operations.

Media

Media

Integrations Supported

Crow Canyon Contract Management

Integrations Supported

API Availability

API Availability

Pricing Information

Per user, Per month

Pricing Information

$500 one-time payment
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

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

PSC Software

Date Founded

1996

Company Location

United States

Company Website

pscsoftware.com/software/ace-essentials/

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

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Quality Management

Not specified

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Response Management
Risk Assessment

Safety Management

Audit Management
Corrective / Preventive Actions
Incident Management
Injury Reporting
Inspection Management
Safety Risk Assessment
Training Management

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