The CARA Life Sciences Platform is made up of different module which make up full Regulatory Information Management.

1. for Regulatory Information Management (RIM)
Do you need to know:
What is approved, and where, globally?
What your affiliates have done locally?
The plans and status of all ongoing regulatory work?
CARA provides this in a few easy clicks

2. CARA provides the optimal solution to the situation – allowing companies
to have a single UI for RIM that simplifies the business users’ experience,
with the RIM data seamlessly connected to submission assemblies and
individual documents, allowing full traceability, impact analysis and an
easy Current Approved View of your products globally.
TheRIMlifecycleofpharmaceuticalproductsfromearlydiscovery,through
development and trials to submission and post-submission tracking,
updates, lifecycles and pharmacovigilance, is extremely complex. At
the heart of managing the process is a combination of the Master Data
on products and the documentation associated with every step of the
process. Traditionally, managing these has involved implementing multi-
ple silo systems with very little inter-system communication and thus data
integrity.

3. How does it work?
The CARA RIM modules provides a pre-config-
ured set of data objects to manage all RIM data.
At the heart is a set of Controlled Vocabularies
(dosage forms, strengths, indications and so on)
that are based on IDMP / SPOR. The next layer
is the company Product information, from prod-
uct families down to Medicinal Products and
Packaged products, as well as substance and
studies management. These two layers togeth-
er capture the information required for IDMP /
xEVMPD purposes, and can be further config-
ured to individual customer needs, as well as
acting as a Master Data Management system
that other systems can query via REST API.
Finally, there are the Events, Activities, Applica-
tions and Registration objects, that are linked in
a cascading fashion to each other, with automa-
tions during bulk creation of e.g. Activities from
Events.
Every object has planned and actual dates and
responsibilities data that can be used for plan-
ning and then for tracking through report dash-
boards. They also have a unique ability to have
supporting documents attached that are not in-
tended for submission but use reference during
the process.
All of this is support by the new Business Process
Management capabilities of CARA that move
simple document workflows to the next level.
CARA RIM COMPONENTS
Submission Forecasting / Planning
Dossier (Assembly) Management
Document Management
Applications, Events and Activities
Product Registration
Commitment Management
Health Authority Interactions
(Q&A, correspondence)
Regulatory Archive of published submissions
Labelling (CCDS to labels, translations
and artwork)
Reporting and Analytics / Integrated
Regulatory Information
Data Management and Information Standards
Design History File – Medical Device
Regulatory Intelligence (2021)
Safety Reporting / submissions
Dossier publishing with our publishing
partners
See our main LIFE SCIENCE SOLUTIONS page
for details of each of the modules.
Over470,000users
andgrowing…

4. www.generiscorp.com