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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

RegDocs Connect equips both operational and regulatory teams with essential tools for creating thorough and compliant documents and records that are ready for submission. Designed with the end user's experience in mind, this solution prioritizes collaboration, automation, and quality as its core principles. Automated workflows streamline the management of the records lifecycle from the initial draft to the final version, allowing your team to maintain full oversight of regulatory documents at all times. By aligning document types with the EDM reference model and eCTD, this system enhances the organization and retrieval of documents necessary for regulatory submissions. Additionally, proprietary features such as PDF/A Publishing, document classification, and distinctive document identifiers create a robust regulatory document management framework that consolidates information from various parts of your organization into a single, navigable solution. As electronic submissions to regulatory bodies become more prevalent and the intricacies of drug development increase, the capacity to generate high-quality, submission-ready content is more critical than ever, ensuring compliance and efficiency in the regulatory process. Moreover, this comprehensive approach not only simplifies the documentation process but also fosters greater collaboration among teams, ultimately leading to improved outcomes in regulatory affairs.

Description

Rimsys provides a single, cloud platform for end-to-end regulatory process digitization and automation. Designed by and for regulatory affairs professionals, Rimsys helps medtech companies reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners. Only Rimsys provides a holistic platform that supports a full range of regulatory activities. Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions. Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions. Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes. Get notified of changing standards, laws, regulations, and guidance documents that impact your products. Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
Montrium Connect
PTC Windchill
SAP ERP

Integrations

Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
Montrium Connect
PTC Windchill
SAP ERP

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Montrium

Country

Canada

Website

www.montrium.com

Vendor Details

Company Name

Rimsys Regulatory Management Software

Founded

2017

Country

United States

Website

www.rimsys.io/products/rimsys-platform

Product Features

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

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