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Reporting |
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Giving
the health industry something MORE
The
Medicines and Healthcare products Regulatory Agency (MHRA)
launch MORE – Manufacturer Online Reporting Environment,
an initiative to optimise communication between Manufacturers
and the Agency using the latest in Internet Technology. |
![MHRA Logo](Images/casestudies/mhralogo.gif) |
The
MHRA
- Providing
advice and guidance on medicines and medical devices.
- Investigates
adverse incidents associated with medical devices
- Regulates
devices and clinical trials
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Exchanges device data with european organisations
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The
Solution
- Secure
report logging system
- Individual
workspace for each Manufacturer
- Report
and Asset library
- Increased
accuracy and efficiency
- Estimated
savings of £25K per annum
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Background
The tremendous success of the launch and subsequent take
up of the agency’s website in 2001, made the MHRA the electronic
centre for health device information in the UK. As well as being
a centre for health information, the site enabled users to report
on devices through a sophisticated data capturing system. The site
however provided no private area for manufacturers where users could
save reports and post follow-ups. Following an extensive survey
with device manufacturers 76% thought online reporting would make
the process more efficient 92% thought that a secure system would
be a viable way of maintaining and updating contact details held
by the MHRA 60% would also use the system as a cataloguing system
for their submitted reports. This lead the agency to embark on Phase
2: Manufacturers Online Reporting Environment (MORE).
Consultancy Process
As the developers of the original site, Charles McKenzie
Consulting were appointed by the MHRA to carry out a requirements
analysis exercise and incorporate the new features into the development
of MORE. Having an established relationship with the MHRA since
the original development, Charles McKenzie were able to identify
with the brief as well as plan for the future direction the agency
planned to take, making the development easily extendable. Charles
McKenzie also had an established understanding of the MHRA’s
infrastructure and were therefore able to integrate MORE with other
systems used within the agency.
Charles McKenzie held a number of workshops
with the agency to identify the environment the agency visualized
the manufacturers using. This activity helped to streamline the
process manufacturers would go through to register with the MHRA
and use their Portal.
The Solution
Each manufacturer has their own data centre on MORE. This
gives them access to all their reports held within the system. Users
can add new reports or create follow-ups to existing ones as new
data becomes available. In addition, graphical images and statistical
data can also be attached to online reports, providing a comprehensive
set of data.
In order to become a part of MORE, manufacturers
must register on the site. Once the account is verified by the MHRA,
manufacturers can start creating reports. Reports created inside
MORE are only accessible to the manufacturer until the report has
been submitted to the MHRA. Submitted reports are locked, but can
be amended through follow-up and trend reports.
A secure connection is established between
the User and the MORE workspace to ensure that data is sent along
an encrypted channel.
“MHRA
expect the application to return cost savings in the first year
of use, to almost cover the cost of the development ”
MHRA |
The Future
Plans are already in place for the next phase of development, which
will provide manufacturers with greater incentives in using MORE.
Data received from other systems will be delivered to the manufacturers
workspace, so users will have a comprehensive set of reports received
from a variety of sources. In addition, an automated data entry
system will ease the task of reporting device information.
“The system promises
to make the UK a good place to launch new products and projects"
Dr David Jefferys, Head of the devices, MHRA |
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