About Charles McKenzie


Case Studies

Contact Us

Business Partners

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.

    The MHRA
  • Providing advice and guidance on medicines and medical devices.
  • Investigates adverse incidents associated with medical devices
  • Regulates devices and clinical trials
  • Exchanges device data with european organisations
    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

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

Charles McKenzie Consulting Limited
John Eccles House
Oxford Science Park