ProcEdge RIMS

ProcEdge RIMS

Sarjen Systems Pvt Ltd
cubeSAFETY

cubeSAFETY

CRScube
+
+

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About

ProcEdge RIMS is a centralized regulatory information management system designed to streamline global product registration and post-registration activities. It replaces error-prone manual methods like Excel with a unified platform that offers real-time access to product data across departments. The system tracks submissions, renewals, and regulatory correspondence with configurable workflows and automated reminders to ensure compliance with varying international regulations. It supports industry standards such as IDMP and meets GxP, GDPR, and 21 CFR Part 11 compliance requirements. By consolidating regulatory data and workflows, ProcEdge RIMS helps companies reduce operational costs and speed up time to market. Its robust query management and audit trail features improve submission quality and regulatory responsiveness.

About

cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Regulatory affairs professionals and compliance teams in pharmaceutical, biotech, and healthcare industries seeking a centralized, compliant platform to manage global product registration and regulatory information efficiently

Audience

Safety-pharmacovigilance teams in pharma, biotech or device companies interested in a tool for adverse-event monitoring, reporting, and safety-case management

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

No images available

Screenshots and Videos

Pricing

$300
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Sarjen Systems Pvt Ltd
Founded: 1998
India
rims.sarjen.com

Company Information

CRScube
Founded: 2010
South Korea
www.crscube.io/solution/cubesafety

Alternatives

Alternatives

SafetyEasy

SafetyEasy

AB Cube
LICENSALE

LICENSALE

Arazy Group
Thrana Safety Database

Thrana Safety Database

Thrana Softech
ViSU

ViSU

DDi
Clienvo eTMF

Clienvo eTMF

Clinevo

Categories

Categories

Integrations

XML
cubeCDMS
cubeCTMS

Integrations

XML
cubeCDMS
cubeCTMS
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