Glemser Technologies is committed to transforming the global labeling
process. Glemsers agship product, xmLabeling, facilitates the tracking and management of labeling content across the complex global label- ing process from the creation of a core data sheet to health authority approval of local labels including variations. xmLabeling is a scalable solution, built on the life sciences standard for content management, EMC Documentum. By applying a unique com- bination of automation and best practices with an open API, Glemser has reduced the complexity and increased the insight into global label management and tracking processes. xmLabeling removes the need for error-prone tracking spreadsheets and facilitates a broader view of how global labeling content is managed. xmLabeling 520 North New Street, Bethlehem, PA 18018 +1 610.317.9400 www.glemser.com Oers one centralized source for local labeling content, translations and variations Ensures end-to-end compliance, reporting and alignment with goals through closed loop management Provides style sheets to automate the generation of agency compli- ant output, such as QRD and SPL formats Replaces spreadsheets with automated workows, tracking and reporting Tracks IDMP information in a centralized location in order to meet the EMAs July 2016 deadline Complies with 21 CFR Part 11 requirements with electronic signa- tures and audit trails Exposes a robust labeling library to support regulatory information management initiatives Leverages the proven compliance and content control of EMCs Documentum platform Incorporates over ten years of production experience into the product design and development Can you access a single source of truth in a central location for your global label content? Can you easily track content changes from the core data sheet to the local label? Are your label translation processes connected to your global label content process? Do you see a need to reduce costs associated with translations? Are you struggling to keep up with changing technology or regulatory requirements? Current Labeling Process xmLabeling enables ecient and eective tracking and management of labeling content across complex global processes. xmLabeling provides simultaneous process control and transparency, a centralized approach to label management and a deep understanding of compliance requirements and best practices built into the product. Benets Enabling Eective Tracking & Management xmLabeling