Presented by Jennifer Linton & Jennifer Perkins at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis. Gambro BCT, a medical device manufacturer, is diving in to the next generation of technical communications. This new environment consists of topic-based XML/DITA-structured authoring, automatic publishing, and the need increase the number of language offerings to support growth in additional and merging markets. All of this is to be done while continuing to follow regulatory guidelines. In this discussion, Jennifer Perkins, the Technical Communications Manager, and Jennifer Linton, the XML/CMS Project Manager, provide helpful tips about each phase of the document lifecycle and what to consider when moving to an XML/DITA-based environment in a regulated industry. Do you have questions about how to support an XML/DITA-based and content and translation management system environment in your industry? This talk will provide you with some helpful tools and answers for you to move forward. After about two and a half years of attempting to move to DITA and trying different content management system approaches, Gambro BCT is finally using the open source authoring standard, a content management system, and a translation management system. This new environment, called GEM (Globalization and English Management), is the basis for many new opportunities at Gambro BCT. They will share a brief overview of the organizational structure, tools infrastructure, and the regulatory standards needed to maintain this new environment. Then they will dive into some of the details about the discussions they had to solidify this working environment. These discussions include the information model, user guide for the content management system, persona descriptions, and process and procedure guides. For example, in their discussions, they determined that the document lifecycle needed to change to encourage regulatory signoff at a more granular level to promote a translations cost savings. The presenters will also share the benefits that they foresee with this new environment as well as some lessons learned and next steps, including implementation of this system to develop training materials.