Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
A scalable, real-time, collaborative, out-of-the box solution for CROs, Life Science Consultants and Industry Stakeholders. Built in an Audit Ready Compliant Cloud environment (ARCC). All 21 CFR Part 11 requirements are met. GxP audit ready. Pre-configured Departmental. Communications with internal and external stakeholder. Secure data integration between remote teams. Collaboration in review and approval. Turn access on/off according to need (EX: auditors), reducing audit prep time from days to hours. Preconfigured to eTMF Reference models & EDM. Intelligent content management tools can improve workflows. Improve document management with real-time collaboration, automatic indexing and co-authoring. Pre-configured, validated system that manages documents and data electronically in accordance with eCTD mandates.
Description
As a regulatory consultancy and technology firm, we assist businesses in adopting international standards, optimizing their internal processes, and promoting rapid expansion on a global scale. Our dedicated team of ISO consultants is equipped to offer reliable advice tailored to meet your management systems needs. With our extensive international experience and a strong background in both hardware and software sectors, we have successfully supported a diverse range of clients. Whether you need to establish a Quality Management System (QMS) with comprehensive documentation or ensure its ongoing effectiveness through efficient document management and automated workflows, we provide essential solutions customized for your unique organizational requirements, catering to both emerging enterprises and well-established businesses. Additionally, our commitment to continuous improvement means we stay updated on industry trends to further enhance your operational efficiency.
API Access
Has API
No
API Access
Has API
No
Integrations
Crow Canyon Contract Management
No
Pricing Details
Per user, Per month
Free Trial
No
Free Version
No
Pricing Details
$250 per month
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Court Square Group
Founded
1995
Country
United States
Website
www.regdocs365.com
Vendor Details
Company Name
Stendard
Founded
2016
Country
Singapore
Website
stendard.com
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
Yes
Electronic Data Capture
Yes
Enrollment Management
No
HIPAA Compliant
Yes
Monitoring
No
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
No
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No
Product Features
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
Yes
Periodic Review
Yes
Version Control
Yes
Document Generation
Batch Processing
No
Collaboration
Yes
Digital Signature
No
Interaction Tracking
Yes
Multiple Output Formats
No
Templates
Yes
Document Management
Access Controls
Yes
Archiving & Retention
Yes
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
Yes
Document Retention
Yes
Electronic Signature
Yes
Email Management
No
File Recovery
Yes
File Type Conversion
No
Forms Management
Yes
Full Text Search
Yes
Offline Access
No
Optical Character Recognition
Yes
Print Management
No
Version Control
Yes