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How Document Conversion Can Impact Regulatory Operations 3 Things You Should Know About Document Conversion
Lightning Fast – Enterprise Scalable – Cost Effective – Flexible Deployment
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TABLE OF CONTENT
1. How Document Conversion Can Impact Regulatory
Operations 3 Things you should know about Document Conversion
2. Think about the entire document life cycle
Creation
During its active life cycle
Retirement
3. Connect all your systems and share
4. Automate
5. Introducing DocShifter: the Switzerland of Advanced
Rendering
Enter DocShifter.
Acceleration
Enterprise Scalability
Easy to use
At the lowest total cost of ownership possible
And there is a lot more than just PDF
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How Document Conversion Can Impact Regulatory
Operations 3 Things you should know about Document Conversion
Advanced rendering. Compliant rendering. High fidelity or hi-fi document rendering. There are a lot
of terms out there related to document conversion. What do they really mean and how can they
make your life within Life Sciences easier?
When you're working in a highly regulated industry, like Life Sciences, compliance comes first. At
the same time, business needs are growing, and there is huge pressure to get to market fast.
Organizing your processes in the most efficient way is key. Advanced rendering plays a big role here.
"This whitepaper broadens the spectrum,
and demonstrates that
advanced rendering is more than just
excellent technology."
Document rendering has been around for a long time. Ever since documents were created, we have
been looking for ways to visualize, print and share in a standardized way. Most organizations have
integrated rendering in some shape together with the implementation of an enterprise content
management solution. In most cases, this was designed years ago, and the world has moved on
since. Regulatory pressure has caused Life Sciences organizations to be very careful in the adoption
of new technology, for understandable reasons. But occasionally, we should take a step back and
analyze the old way of doing things. You should look for improvement areas. Advanced rendering
brings the efficiency gains you are seeking, while easing your ability to ensure technical
compliance.
Advanced Rendering is much more than (the process of) transforming a relevant source
document to a PDF file. It starts with challenging how you do things today. Identify those
departments in your organization that are actually rendering documents. No surprise, that is not just
regulatory. Marketing, labelling, HR, … many documents are being converted during a specific stage
of their life cycle. In addition, external documents that are flowing into the organization likely require
some form of standardization. Think of information flowing in through acquisitions, documents
coming from partner organizations, CROs, etc.
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Have a close look at your authoring guidelines. Implement small changes early in the process that
save valuable time further down the road. Pay attention to regional software settings, they may
cause incorrect renditions to be created.
Advanced rendering is also rethinking the entire process, as well as the solutions in place today.
"The creation of technically compliant PDFs
should not be left until submission time.
For many documents, this step can be moved
earlier in the document life cycle."
Saving valuable time when you need it most, during submission creation. Advanced rendering is
about increasing efficiency, by setting the different output parameters to the requirements of the
different regulatory authorities. One time. Centrally. And not leaving this decision in the hands of an
individual document author.
Advanced rendering is about drastically reducing infrastructure and indirect licensing costs. At the
same time, being able to deal with peak loads. It can deal with these increased periods of high
activity. How? Through massive scalability. So that when you need it, tight deadlines can be met. In
highly regulated industries, regulatory pressure can slow down innovation. Advanced rendering
can pick up the pace and win valuable time back.
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How to go beyond technology? 3 guiding principles.
The first step is to make an inventory throughout the enterprise of all rendering processes in place
today. This is crucial to evaluate the as-is-situation. Subsequently, we share 3 guiding principles on
how that existing process can be improved.
1. Think about the entire document life cycle
Advanced rendering is a lot more than just producing a high quality technically compliant PDF right
before the submission. It covers the entire document life cycle: from cradle to grave.
Creation
Documents are generally created internally. But this is not always the case. For example, digital files
enter your organization through an acquisition, or a collaboration with a partner, through CRO’s or in
many other ways. In that case, you might want to standardize those incoming files to a unified file
format, or rendition, before sending these files to your content repositories.
These external documents can be in obsolete and old file formats that are no longer used within your
organization. Then you want those files updated to the latest file format. So they can again be used
by your organization, and continue to deliver value.
You might want to validate incoming documents towards specific technical requirements. Are they
the right file formats? Can we increase the traceability and use of these files by extracting relevant
metadata?
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During its active life cycle
Why wait to the publishing stage to create fully compliant PDFs? Begin technical review months
earlier and take the stress away right before submission. Populate document properties available in
your content management system automatically.
Merge documents together to 1 single file, for Veeva Binders, ZIP files, Documentum Virtual
documents. Automatically split documents. Set maximum file size limits. Move compliance earlier in
your submission processes through advanced rendering. Save valuable time and money.
Retirement
When the end of an active document life cycle is reached (f.e. product is taken out of the market), all
that product related documentation needs to survive. Converting these documents to a future proof
format such as PDF/A is key to ensure readability and accessibility.
Advanced rendering plays a role in all scenarios, from document creation to document retirement.
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2. Connect all your systems and share
In conversations with both large and small organizations worldwide, we learned that the rendering
process is not centralized. Desktop tools are being used, causing inconsistent output and leading to
significant associated license costs. We propose to move the rendering process away from the
individual user and centralize it. This significantly reduces the risk of manual errors.
Centralizing this rendering service has additional benefits. More departments can be served, across
business units and geographies. The centralized service can be connected to many (see visual
below), document management systems, regulatory information management (RIM) platforms or
other specific platforms within your organization. This way it is also Integrated with every system
that needs document conversion at some point. Increasing consistency and eliminating the risk that
comes with manual interventions.
Centralizing and sharing is more than just practical. Cost savings through centralization are huge.
Real life examples from our customers show potential infrastructure cost savings of 70%.
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3. Automate
High levels of automation are reached through the implementation of shared document rendering
service. The supporting centralized systems are set up once and run in the background. From a
single source file, multiple renditions can be made. Creation of technical compliant output for multiple
regulatory authorities simultaneously is just a click away. This is a proven time saver. We spoke to
50+ companies, both large and small, and all agreed that the impact of such a setup takes a huge
burden away.
Below is a simple example of a workflow, picking up a file, and rendering it to the requirements of
FDA, PMDA, EMA and ROW. All in one go.
This is achieved for high volumes, in a highly scalable way, so that the system easily copes with peak
workloads when you need it most.
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Introducing DocShifter: the Switzerland of Advanced
Rendering
We shared why this Advanced Rendering is more than just having the right technology in place and
set out 3 guiding principles on how this can be improved.
To make all the above happen, the technology needs to be able to cope: scalability, speed,
connectivity, easy deployment.
We will now focus on those technical features which a rendering system needs to be truly advanced.
Enter DocShifter.
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Acceleration
You do not want to wait for a document to be rendered. Time to market is key, as the rendering
process is typically one of the latest steps before submission. So, you want it to be lightning fast.
That is what we are. In 1 minute, we render 155 documents (10 pages) to fully ICH compliant PDFs.
And this process only takes us up to 10x the speed that most companies are seeing today.
You also do not want memory leaks or other manual interventions to slow you down.
Enterprise Scalability
To deal with growing workloads, you need a system that is built to scale. A system that can run on
any platform (Linux, Windows) – or even virtual (in a Docker container). You need a system that
grows with your needs during peak loads.
Moreover, DocShifter easily connects to all your existing document repositories. Either via a native
integration or a web API. We enhance the capabilities of your RIM or document management
platform. We are neutral and integrate with the systems that are in place. That’s why we are being
called “the Switzerland of advanced rendering”. Due to this architecture, multiple business units and
departments share the same platform, while consistency is ensured.
Easy to use
DocShifter recognizes the incoming file formats automatically, no user intervention required. The
administrator uses an intuitive web interface to create workflows for your documents. This workflow
is tailored to your needs and follows major guidelines: where do the documents reside (Input), what
do we want to do with them (Transformation), and where do they go after transformation (Output).
Once you define a workflow, these configurations are stored and can be reused for maximum
efficiency.
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In addition, DocShifter comes with predefined configurations that are set up according to the
specifications of the various health authorities (FDA, PMDA, EMA, …)
At the lowest total cost of ownership possible
By design, DocShifter does not require any native applications to create the rendition. So, no need for
expensive licenses on the server. No need to have individual tools on every desktop. Through
centralization, we have seen customers saving in excess of $500.000 per year, in related licensing
costs alone.
In addition, DocShifter helps drastically reduce current IT Infrastructure. Most of our customers
handle the same workload with ⅓ of the servers they previously needed.
And there is a lot more than just PDF
DocShifter can handle +300 incoming and outgoing file formats. This opens endless document
conversion scenarios.
● Did your organization acquire another company, and do you need to migrate 100.000’s of
files? Or are you actively collaborating with partner organizations? Why not standardize these
incoming files or upgrade them to the latest file format? Generate thumbnails on the fly.
● Email is a growing source of incoming information. Do you need to keep track of all
conversations with the regulatory authorities? Automatically convert your incoming emails and
their attachments to a standard format and store these centrally.
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● Are you building an enterprise archive? And are you seeking to reduce your dependence on
native applications? Transform to formats like PDF/A or TIFF to guarantee long term access to
your company’s intellectual property.
Advanced rendering allows you to enrich your documents, to add watermarks, and pagination where
needed. Documents from multiple sources can be merged or split. Hyperlinks and Table of contents
correctly colored and styled.
DocShifter is an all-in-one document conversion solution, with major benefits like increased speed
and reduced costs.
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Lightning Fast – Enterprise Scalable – Cost Effective – Flexible Deployment
Geert Van Peteghem
CEO
Mobile : +32477220993
Paul Ireland
VP Life Sciences
Mobile : +447393298623
Feedback or questions? Contact us.
