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Transforming Global Label Management Processes

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