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Description
ProcEdge Regulatory Information Management System (RIMS) provides companies with a powerful, centralized platform to manage complex regulatory requirements for their entire global product portfolio. Moving away from traditional Excel-based tracking, it offers a single source of truth that connects multiple departments, providing 360-degree visibility and real-time updates on product registration, license maintenance, and post-registration activities. The platform enables detailed planning and tracking of submission timelines tailored to country-specific regulations, helping users meet compliance standards and reduce costly errors. It features configurable data models, automated email notifications, and a robust workflow engine that streamlines query management and response tracking. ProcEdge RIMS complies with global standards like IDMP and regulatory frameworks including GxP, GDPR, and Part 11. By eliminating redundant systems and manual data entry, it significantly reduces operational expenses and accelerates health agency approvals. The system’s audit trails and electronic signature capabilities ensure data integrity and regulatory reliability. Overall, it empowers regulatory professionals to make faster, informed decisions and maintain product marketability efficiently.
Description
The Vault RIM Suite offers a comprehensive platform for managing regulatory information from end to end. By centralizing global regulatory workflows on a cloud-based system, it enhances visibility, data quality, and responsiveness for life sciences organizations. This allows companies to adapt swiftly to shifting regulations while improving efficiency throughout the submission process, from planning to final publication. The platform facilitates collaboration among headquarters, affiliates, and partners, all within a unified RIM system. Furthermore, it guarantees that teams produce regulatory content that is both reliable and maintains high data integrity. Veeva Vault Registrations oversees product registration details on a global scale, covering registration status, variations, and interactions with health authorities. Its adaptable data model is designed to incorporate IDMP data points and will keep pace with changing regulatory data standards. Additionally, Veeva Vault Submissions optimizes the submission planning process by automating various steps in the regulatory workflow, leading to significant time savings and improved outcomes. This unified approach ultimately empowers companies to navigate the complexities of regulatory compliance with greater ease and precision.
API Access
Has API
API Access
Has API
Screenshots View All
No images available
Integrations
5X
Indent
Pricing Details
$300
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
Sarjen Systems Pvt Ltd
Founded
1998
Country
India
Website
rims.sarjen.com
Vendor Details
Company Name
Veeva
Country
United States
Website
www.veeva.com/products/vault-rim/