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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
Enhance study efficiency, ensure regulatory compliance, and prioritize patient safety with Alpha Clinical Systems' electronic drug inventory management system (DIMS). By minimizing site errors and decreasing workload, you can achieve real-time transparency in your operations. The comprehensive web-based system, ez-DIMS, optimizes drug and device distributions at the site, effectively eliminating transcription mistakes. With seamless integration to ex-SourceDocx, it automatically tracks supply disbursements, offering instant visibility of the drug inventory. Transition from cumbersome and error-prone manual processes to the intuitive ez-DIMS platform. Furthermore, site workloads can be alleviated through user-friendly scanners that swiftly and accurately log study supply inventory and accountability across patient, site, and study categories. Notably, drug inventory violations at clinical sites rank as the second most frequent finding during regulatory inspections. By utilizing QC cross-checks between ez-DIMS and ez-SourceDocx, you can significantly decrease medication assignment and dispensation errors, enhancing overall compliance and safety protocols. This transformation not only supports effective management but also fosters a safer environment for patient care.
API Access
Has API
API Access
Has API
Screenshots View All
No images available
Integrations
ez-SourceDocx
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
Alpha Clinical Systems
Country
United States
Website
alphaclinicalsystems.com/ez-dims/