9/19/2014 PDF Association Newsletter: Issue 33 | PDF Association

http://www.pdfa.org/2014/04/pdf-association-newsletter-issue-33/ 1/5
PDF Association Newsletter: Issue 33
PDF in Life Science
PDF Association | April 17, 2014
Contents
Evolving Document-Centric Processes with Advanced Rendering to PDF in Life
Science
Feature Article
Meeting Document Requirements in Life Sciences: The Art of Avoiding the
Resubmit
PDF Association Members Present Themselves
Adlib
Events
New Members
Evolving Document-Centric Processes with Advanced Rendering to PDF in Life Sciences

John Hanrahan, Adlib, Principal Life Sciences Practice
Having worked in the Life Sciences field with a document-centric focus for many
years, Im very familiar with the stringent document guidelines that exist.
Countless hours are spent across organizations formatting submissions and
reports, ensuring hyperlinks are the correct blue and page margins are the right
size. In a process with a lot of manual intervention there is considerable room for
human error. Often, document guidelines are not visible to the human eye such
as a page margin of 3/4 versus 2/3 and can be easily missed by end users.
Converting documents to PDF, and automating such a process across the
enterprise, can significantly reduce or eliminate the possibilities of error, thereby
increasing the chances of meeting strict compliance regulations, saving re-work
time, and reducing resource costs.
When deciding to employ an Advanced Rendering solution to automate document-
to-PDF conversion across the enterprise, its important to ensure that the product
can work with the existing and multiple sources of content. This way you can
avoid bogging down end users with extra technical details they need to remember,
and IT professionals with additional systems they need to manage. By integrating
directly with existing Enterprise Content Management, Product Lifecycle
Management and Workflow systems, end users see a seamless and consistent
process for converting their documents into high-fidelity, compliant PDFs. A
number of other benefits can also be achieved:
Continuity of business processes across the organization can be harnessed
Auditable trails of transactions and activities can be maintained
Cost benefits can be leveraged
Content growth across the organization can be easily managed
Data and content can be tagged, indexed and cataloged to increase
searchability
Unstructured data, including email, can be preserved in regulatory formats
Dated and unsupported rendering solutions can be formally retired
The Life Sciences organizations we work with including pharmaceutical, medical
device and biotechnology firms use Advanced Rendering to PDF in a number of
different ways, but the overall goal is to increase the efficiency of document-
centric processes. Here are a few use cases for high-quality PDFs within Life
Sciences firms:
Enhancing unsearchable content: Submissions to governing bodies are
generally comprised of multiple files, many of which are scanned images and
documents in which the text is unsearchable. By harnessing Optical Character
Recognition technology included with high-fidelity PDF conversion tools users
Members News Products Downloads Videos Discussion Forums Login English
9/19/2014 PDF Association Newsletter: Issue 33 | PDF Association
http://www.pdfa.org/2014/04/pdf-association-newsletter-issue-33/ 2/5
can enrich submission content by making all content text searchable, including
that from scanned images.
Ensuring compliance: Establishing FDA compliance is a requirement, as is
adhering to internal document regulations. Often, compiling documents from
multiple native authoring platforms and versions can be complicated when
keeping compliance guidelines in mind. Advanced Rendering documents to PDF
format automates the compliance of important assets across the organization.
Adlibs familiarity with worldwide regulatory requirements has resulted in a
solution that combines highly accurate document conversion, the flexibility to
adapt to a wide range of regulatory requirements, and workflow tools to
streamline complex processes.
Unifying content across platforms: Many organizations use multiple Enterprise
Content Management systems, plus Product Lifecycle Management and Workflow
solutions, not all of which communicate well with each other, but all of which
have PDF conversion needs. By integrating directly with existing platforms,
Advanced Rendering unifies a diverse range of publishing needs into a single,
cohesive environment, resulting in compliance benefits and cost savings in the
millions.
Archiving for the long term: Storing corporate assets whether born digitally
or scanned from paper sources in a format that is usable, accessible and
viewable over an indefinitely long period of time is an important, and often
regulated, requirement for many Life Sciences organizations. Digital archiving in
PDF and PDF/A format has many benefits, but can be intrusive to end users
workflow if its not easily integrated into current systems. Advanced Rendering
automates the archiving process and streamlines the workflow by integrating with
current document practices to satisfy the internal and external requirements for
long-term document storage.

Feature Article
Meeting Document Requirements in Life Sciences: The Art of Avoiding the Resubmit
Jeff Brand, Director Product Management
As in many industries, Life Sciences requires strict adherence to document
processes and guidelines. The lifeblood of a companydata and informationis
often locked up in diverse systems and applications, each using its own file
formats. In Life Sciences organizations including pharmaceutical, biotechnology
and medical device manufacturers this can be anything from clinical trial
content to FDA submissions. Having diverse content proliferated across
departments, business units and international borders can make it difficult for
workgroups to collaborate, planners to envision the large-scale trends affecting
company operations, and administrators to capture and archive the records and
transactions vital to business. Converting documents to standard PDF format
eliminates the issues associated with having content in different file formats, and
increases the opportunity for collaboration and efficiency of document-centric
processes.
The Life Sciences industry has two main challenges when it comes to document-
centric workflows:
Accuracy is paramount: The regulatory approval process is rigorous. Even a
single footnote out of place in a thousand-page report can force a
resubmission.
Delays are costly: Time to market is critical. Delays in drug approvals can
cost up to $1 million per day and impact more than a decade of research.
Delays have even larger consequences for patients who are waiting for
treatments.
The FDA and EMA have very specific and strict regulations that submission content
must comply with. When dealing with submissions that can range from several
hundred pages to several thousand pages, a considerable amount of resource time
and effort goes into ensuring each page in the submission meets the regulatory
guidelines. Converting important documents, such as FDA submissions, to high-
fidelity PDF decreases the risk of non-compliance.
9/19/2014 PDF Association Newsletter: Issue 33 | PDF Association
http://www.pdfa.org/2014/04/pdf-association-newsletter-issue-33/ 3/5
The FDA notes all of their requirements online, so I wont regurgitate them here,
but I will point out a few that I think users often have trouble with:
Hypertext links in text should be designated by rectangles using thin lines or by
blue text, and must go the correct page (so reviewers can access all of the
information).
All pages must have a margin on the left side (so if the document is printed
and bound, no information is cut off).
All text must be searchable, and scanned images and documents must be
subject to accurate Optical Character Recognition (so reviewers can copy and
paste content when discussing items in context).
Non-standard fonts must be embedded (so special characters such as
mathematical or chemical formulas are not misrepresented).
Page orientation should be correct for reading (so reviewers dont have to
manually rotate documents).
The PDF must be an exact representation of the original document, which is
usually a Microsoft Word file (so no content is missing or distorted).
The solution for these high-stakes document challenges lies in the Advanced
Rendering process, which automates and enhances the document-to-PDF
conversion process eliminating manual intervention and human error associated
with meeting stringent document requirements. In short, to avoid the resubmit,
you must not only adhere to the PDF standard, but you must ensure your PDF is
compliant.
With Advanced Rendering to high-quality PDFs, Life Sciences companies can
convert and combine content reports, drawings, charts and images into high-
quality standardized assets to achieve some important benefits across the
organization:
Greater efficiency in the regulatory approval process: submission-ready
PDFs that comply with the sectors regulatory requirements, including the FDA,
EMA and eCTD submission guidelines.
Workflow automation: streamlined and automated workflow including
reading email attachments and properly archiving and directing that content.
Improved distribution across devices: consistent, portable format that can
be viewed across PCs, laptops, tablets and mobile phones.
Archiving: conversion of paper files scanned into archive-quality digital PDF or
PDF/A files to reduce physical storage needs.
Increased accuracy by reducing human error: automating the document
transformation, minimizing the need to perform rote tasks and the potential for
human error.
Collaboration: centralized, standardized approach for business units,
increasing communication.
Simplified IT requirements: streamlined IT processes, reduced costs and
improved productivity.
Ensured long-term access: transformation of digital assets, contracts and
reports destined for long-term retention into PDF/A, the always-accessible
format.
While the requirements, guidelines and specifications for Life Sciences documents
are many, they can be streamlined using Advanced Rendering solutions. By
converting documents to PDF across the enterprise, Life Sciences organizations
can ensure consistency, compliance and cost efficiency.

PDF Association Members Present Themselves
Adlib
As the trusted expert in Advanced Rendering, Adlib specializes in the conversion
and assembly of corporate assets into high-quality, searchable PDFs to
improve collaboration, compliance, document security, archiving procedures and
overall efficiency of business processes. Adlib integrates with and leverages
leading Enterprise Content Management systems, including EMC Documentum,
IBM FileNet, Microsoft SharePoint and OpenText with workflow-based business
rules for intelligent document conversion.
Adlib provides the document conversion, publishing and workflow foundation that
increases productivity in businesses worldwide and the effectiveness of people
across organizations, while supporting compliance with internal processes and
regulatory bodies using standard electronic document formats such as PDF, PDF/X
and PDF/A.
Products and Partnerships
Adlib PDF is the industrys first complete Advanced Rendering platform that enables document-to-PDF
transformation across the entire document lifecycle. By automating the conversion of corporate documents into
9/19/2014 PDF Association Newsletter: Issue 33 | PDF Association
http://www.pdfa.org/2014/04/pdf-association-newsletter-issue-33/ 4/5
accessible and usable digital assets we streamline document-intensive business processes to improve collaboration,
increase efficiency, mitigate risk and reduce costs company-wide.
Adlib helps organizations around the world to become more productive, reduce
errors and inconsistencies, and realize significant cost savings.
Being the trusted technology provider of Global 2000 organizations, Adlib brings
over a decade of expertise supporting more than 5,500 international companies
and government organizations. Adlib partners with more than 100 industry
leading software vendors such as EMC, IBM, Microsoft, OpenText, K2, Nintex and
Dassault. Adlib is a proud Microsoft Certified Gold Partner, Gold Certified ISV
Partner, EMC Certified Solutions Partner, as well as a US Government GSA
provider. Working with our valued customers in a wide variety of industries
including Life Sciences, Financial Services and Government, we help organizations
capture and preserve corporate memory, automate processes, mitigate risk,
adhere to regulatory compliance and improve competitiveness.
For more information, visit www.adlibsoftware.com
Events
June 3-4, 2014: ECM World, Dsseldorf, Germany
PDF Association is part of the event for document management in Dsseldorf,
Germany.
PDF Association at ECM World
June 16-17, 2014: PDF Days Europe 2014, Cologne, Germany
Since 1993 PDF technology has grown from an invention by a single
company to a gigantic ecosystem with thousands of vendors. From a
proprietary file-format PDF is now part of the global IT infrastructure;
an open and democratically-managed ISO standard at work in almost
every sector of almost every economy worldwide. PDF is a Big
Subject. PDF Days in Europe 2014, an educational event created by
the PDF Association, can be your guide.
See the detailed agenda: http://www.pdfa.org/2014/03/pdf-days-europe-2014-
agenda/
New Members
WinHouse Software; Colombia
WingArc 1st Inc.; Japan
Software602; Czech Republic
IDRsolutions; United Kingdom
Solimar Systems Inc.; United States of America
letterscan GmbH & Co. KG; Germany
About the PDF Association
The PDF Association is geared towards developers of PDF solutions; companies
that work with PDF in document management systems (DMS) and electronic
content management (ECM), interested individuals, and users who want to
implement PDF technology in their organizations. Although the Associations
original members were predominantly from German-speaking countries, the PDF
Association now boasts members from over 20 countries worldwide.
Contact
Association for Digital Document Standards e.V.
PDF Association
Thomas Zellmann
Neue Kantstr. 14
D-14057 Berlin
Phone: +49 30 39 40 50-0
Fax: +49 30 39 40 50-99
info@pdfa.org
http://www.pdfa.org
Unsubscribe
You are receiving this newsletter because you are registered for the PDF/A News.
If you do not want to receive further news, please answer with UNSUBSCRIBE.
About PDF Association
9/19/2014 PDF Association Newsletter: Issue 33 | PDF Association
http://www.pdfa.org/2014/04/pdf-association-newsletter-issue-33/ 5/5
Founded in 2006 as the PDF/A Competence Center, the PDF Association exists
to promote the adoption and implementation of International Standards for PDF
technology.
More about PDF Association