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What is Rimsys?
Rimsys offers a comprehensive cloud-based platform specifically designed for the complete digitization and automation of regulatory processes. Tailored by regulatory affairs experts for their peers, Rimsys enables medtech companies to minimize repetitive tasks, accelerate their market entry, swiftly adapt to evolving regulations, and enhance collaboration among internal teams, partners, and affiliates.
What sets Rimsys apart is its all-encompassing platform that facilitates a wide array of regulatory activities. Users can leverage regulatory intelligence along with digital templates to refine their regulatory strategies and simplify submission processes. The platform allows for the creation of compliant, submission-ready documentation and the consolidation of PDF packages for both electronic and print submissions. Moreover, it enables users to digitally gather and uphold evidence of compliance while linking to pertinent standards and receiving alerts about any changes. Rimsys ensures that users stay informed about modifications in standards, laws, regulations, and guidance documents affecting their products. Additionally, the platform offers the ability to generate self-service reports on applications, products, and countries, allowing users to track where their products can be marketed and their current registration statuses, thus further enhancing regulatory efficiency.
What is RegDocs Connect?
RegDocs Connect provides operational and regulatory teams with vital tools aimed at producing comprehensive and compliant documents and records that can be easily submitted. This solution is thoughtfully crafted with the user experience as a priority, emphasizing collaboration, automation, and quality at its foundation. The automation of workflows simplifies the entire records lifecycle, from drafting to finalization, ensuring that your team has complete oversight of regulatory documents throughout the process. By integrating document types with the EDM reference model and eCTD, this system significantly improves the organization and retrieval of documents crucial for regulatory submissions. Furthermore, unique features like PDF/A Publishing, document classification, and distinct document identifiers establish a powerful regulatory document management framework that brings together information from various sectors of your organization into one cohesive and navigable solution. As the trend toward electronic submissions to regulatory agencies continues to rise and the complexities of drug development evolve, the ability to produce high-quality, submission-ready content is increasingly vital for maintaining compliance and enhancing efficiency. In addition, this holistic approach not only streamlines the documentation process but also encourages deeper collaboration among teams, which can lead to more successful outcomes in regulatory affairs and improve overall productivity. Such advancements in regulatory document management are essential for adapting to the rapidly changing landscape of compliance requirements.
Integrations Supported
Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
Montrium Connect
PTC Windchill
SAP ERP
Integrations Supported
Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
Montrium Connect
PTC Windchill
SAP ERP
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
Rimsys Regulatory Management Software
Date Founded
2017
Company Location
United States
Company Website
www.rimsys.io/products/rimsys-platform
Company Facts
Organization Name
Montrium
Company Location
Canada
Company Website
www.montrium.com
Categories and Features
Categories and 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