RegDoc eSafeMedPoint Digital
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Sierra QMSSierra Labs
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Related Products
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About
An eReg platform built with the study site in mind. Fast implementation, no forced workflow, intuitive design and function. Try RegDoc eSafe free today! A secure lock-box for source documents, with tools that make it easy to transfer, redact and assign role-based, time-limited remote access to these sensitive documents. RegDoc eSafe is designed for fast, flexible configuration, intuitive use with minimal training, and a thorough but streamlined validation process. Streamlined implementation process to get your clinical study sites up and running quickly. Regulatory binder templates pre-loaded into your site for easy access. User upload and access control configuration. Admin and user training sessions. MedPoint is committed to compliance and walks you through the necessary steps to validate our software. MedPoint is regularly audited by study sponsors and has long experience developing and supporting validated systems.
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About
Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Researchers and analytic experts searching for a solution to improve and manage their operations
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Audience
Organizations in need of a healthcare and life science Quality Management system
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Contact MedPoint Digital for pricing details.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationMedPoint Digital
United States
www.medpt.com/site-services/
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Company InformationSierra Labs
United States
www.sierralabs.com/quality-management/
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Alternatives |
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Categories |
Categories |
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Document Control Features
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management Features
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
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Document Control Features
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
CAPA Features
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance Features
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Version Control Features
Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback
Quality Management Features
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Risk Management Features
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
Internal Controls Management
IT Risk Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment
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Integrations
No info available.
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Integrations
No info available.
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