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SPL Conversion Workflow |
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The SPL Conversion Challenge for
Life Sciences Products Manufacturers
The first step in meeting your needs to create
FDA-compliant Structured Product Labeling (SPL) is to
convert your current product labels into usable
XML-format. Once converted to XML the job is only
half complete. The next step in the process is
converting your XML-formatted information into compliant SPL. The entire conversion process is a significant and
complex challenge, not a simple cut and paste exercise.
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Add to these challenges the addition of the
Physician Labeling Rule (PLR) business rules and
regulatory requirements and all of your label validation
and content management needs become even more
complicated.
Your Content of Labeling exists today in one or possibly many
file formats, such as Microsoft® Word, Adobe® PDF or
Quark®. We are experienced in converting these and other
file formats into SPL and accurately handling all source
elements including text, images (JPEG, TIFF, etc.), tables, chemical structures and formulas, ordered
and unordered lists, and detailed scientific drug
information. In addition to these electronic formats, we
also can convert label content that might still exist on
paper.
We realize the importance of clean, legible labels.
Sometimes the available chemistry images within a label are not
exactly perfect. In these circumstances, with your
concurrence, we redraw the chemical compounds, when
needed. Currently, for our work in support of the United States Patent and Trademark Office (USPTO),
we accurately redraw thousands of chemical compounds
every week (see Electronic Publishing).
Given the many challenges of the SPL process, converting
your current product label data into compliant SPL is
best done by professionals who are not only
experienced in transforming large volumes of data into
usable information and maintaining it thereafter, but
also extremely well versed in the FDA regulations
surrounding the validity and acceptance of your label in
a timely fashion. Additionally, you will find the costs of outsourcing your label conversions is less than the costs of doing your own conversions internally. |
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SPL Experience
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XML to Rendered Document |
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We have already converted over 3,500 labels, from a
wide variety of input formats, into SPL and
SPL-PLR compliant
documents.
Reed Tech combines our leading-edge data
conversion and data management capabilities
to meet the needs of life sciences manufacturers in
complying with today's SPL requirements.
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Our customers include
over 115 life sciences clients, including 4 of the top 5 innovators and 3 of the top 5 generics in the world,
some with more than 100 labels, and
also include many smaller firms, each with a single label to
manage. No matter the size of your company and volume of
your need, Reed Tech has the knowledge, experience and
resources to provide quality results.
Contact Reed Tech for more information
Please
contact Ben McGinty, for more information about SPL Conversion
services
Ben McGinty
Senior Director, Business Development
bmcginty@ReedTech.com
+1-215-441-6466
Reed Technology and Information Services
Inc.
7 Walnut Grove Drive
Horsham, PA
19044
U.S.A.
+1-215-441-6400
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Reed Technology and Information Services Inc. (Reed
Tech), based in Horsham, PA, is a leader in data capture, conversion and management. Reed
Tech is a member of the
LexisNexis Group headquartered in New York, NY, a leading global provider of comprehensive and authoritative legal, news and business information and tailored applications.
©
Reed Technology and Information Services Inc. All Rights Reserved. |
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