Main Page

Welcome!

This site supports the installation, deployment and full documentation of OpenRIMS modules for Registration Process Management (RPM) and Pharmacovigilance Management (PVM).

Navigation & Language

Please click here to see an index of all content of this Wiki: https://wiki.openrims.org/index.php/Special:AllPages

To change language please open this website in Google Chrome and then Right Click to select Translate to select a different language. The Wiki use Google Translate which might not always be 100% accurate.

What is a RIMS?

The purpose of a Regulatory Information Management System (RIMS) is to automate and digitalize the processes and work routines at a National Medicines Regulatory Authority (NMRA).

OpenRIMS serves that purpose and is built on Common Standards for RIMS.

Localization

OpenRIMS is Free and Open Source Software (FOSS) and can from the browser be localized to country procedures and needs like language.

Getting Started

The Common Regulatory Function

OpenRIMS M2 - Marketing Authorization
OpenPV M3 - Pharmacovigilance
OpenRIMS M4 - Import/Export Certificates - Coming Soon!
OpenRIMS M5 - Premises and People Registration - Coming Soon!
OpenRIMS M6 - Inspection - Coming Soon!
OpenRIMS M8 - Clinical Trial Approval - Coming Soon!

Making content contributions

PLEASE NOTE!

Use the following syntax to name the pages:

"System name"_"Page/Subject Title"_"Part Number"

Example:

OpenRIMS_Cleaning the Database_Part 1

All new content is subject to review and approval.

OpenRIMS reserves the right to edit or delete content or pages as appropriate if the content is not relevant for Regulatory Information Management Systems.

User Guides for each Module

User Guide for Pharmaceutical Manufacturers, Pharmacy Owners and other Clients of Regulatory Authorities
User Guide for Regulatory Staff
User Guide for System Administrators