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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 LabRelations?

LabRelations stands out as a cutting-edge and versatile laboratory platform aimed at streamlining and enhancing scientific and testing processes through the integration of vital modules such as LIMS, ELN, CTMS, and EDC into a unified system that supports everything from sample tracking to experiment documentation, as well as study management and compliance reporting. This all-encompassing tool effectively reduces manual labor, minimizes inaccuracies, and eliminates data silos, allowing laboratories to centralize all pertinent information in one accessible location. Users can create workflow automations based on specific rules, connect instruments and external systems, and maintain comprehensive audit trails to ensure compliance with regulations like GxP and 21 CFR. Additionally, LabRelations offers the capability to customize objects, forms, views, and permissions according to the distinct needs of each laboratory, fostering improved collaboration across different functions while providing real-time insights that span research, quality assurance, clinical studies, and stringent regulatory environments. Consequently, this platform not only enhances operational efficiency but also bolsters the reliability of laboratory processes, paving the way for more innovative scientific advancements. By adopting LabRelations, laboratories can prepare themselves to meet future challenges with greater agility and effectiveness.

Media

Media

Integrations Supported

Crow Canyon Contract Management

Integrations Supported

Crow Canyon Contract Management

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

LabRelations

Company Location

United States

Company Website

labrelations.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

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

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

ELN

LIMS

Audit Trail
Certificates of Analysis
Data Import / Export
Electronic Laboratory Notebook
Inventory Management
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Specification Management
Workflow Management

Medical Lab

Audit Trail
Data Analysis Auditing
Data Security
EMR Interface
Fax Management
Lab Instrument Interface
Multi-Location Printing
Online Instrumentation
Physician Test Panels
Procedure-Based Billing
Sample Tracking

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