Case Study 06
was looking for an enterprise workflow/process management
system to automate their entire Regulatory Affair
(RA) department. They wanted a system that would have
the ability to collaborate and track various regulatory
processes including filings, product development,
audits, tracking of complaints, ethics hotline, etc
and provide reports on the data across multiple areas
of the system.
There was no
formal integrated system available for the entire
RA department. Business units were using local databases
or spreadsheets to support individual processes. This
problem presented the client with the need to implement
an enterprise compliance management system to mange
these processes and render meaningful data/reports
for the entire department.
- Azilon provided a phased
implementation approach under a single enterprise
web based compliance platform starting with the
Filing and Product development automation. Additional
process automation solutions were built on the same
- The platform provided common
compliance built-in features including centralized
organization structure, user management, workflow,
alerts, email integration, document repository,
calendar that were shared between various systems.
- The solution also provided
integration with the clients marketing department
for automation of the advertisement piece filing
- The solution provided a
dynamic form builder allowing the RA department
to the design custom filing forms as per the agency
the implementation of the D'RisK-Compliance
solution, the client was able to efficiently
manage and track their filing and product
development process under a single platform.
It provided effective
management control and oversight with
increase visibility on critical issues
that needed immediate action. Filing effort
and timelines were drastically reduced.
Regulatory fines were avoided with effective
resource allocation and access to cross
function dynamic reports.