MIKADO

The MIKADO (Management of Information, Knowledge and Associated Documents Organization) initiative has been set up to provide enterprise-wide, best practice, validated Electronic Document Management Systems (EDMS), audit-trailed with traceable version history, direct worldwide access to documents, enhanced retrieval, review and approval processes and improved compliance and security. The new systems include supporting tools, standards and processes to support all UCB regulated environments.

MIKADO is composed of multiple projects, including two current projects: MIKADO Regulatory Submissions and MIKADO Controlled Documents.

A timely NDA review depends not only on the FDA, EMEA, or other Agency, but also on UCB submitting complete, well-organised, and easily navigated regulatory submissions.

The initial focus of MIKADO was on an EDMS and other tools to enable delivery of regulatory submissions in an electronic format for the Common Technical Document (eCTD) to regulatory authorities. These tools, standards and processes are being implemented in 2008 and will have a positive impact by changing the way regulatory documents are authored, managed, assembled and submitted by UCB, as well as how our submissions are reviewed by the Agencies. The key benefits will be reduced time to compile and submit marketing applications (increasing revenue) and reduced time to subsequent market submissions (increasing revenue generation). This is critical to offset the significant increase in the number of major submissions resulting from our growing product portfolio.

Embracing one single electronic system for controlled documents not only reduces the time to author, review, and to approve documents in a global environment, but also the time spent managing, accessing and distributing documents.

The MIKADO Controlled Documents project was initiated in late 2007. The objective is to implement a solution for the electronic management of controlled documents regulated by GxP throughout the functions within UCB. This project will enhance the management and distribution of controlled documents and enable business areas to better obtain an overview of the different systems relevant to their operations and to retrieve the documents in due time during an inspection. Some key benefits include streamlined review cycles (increasing quality) and heavily reduced manual paper-based distribution process (decreasing costs).