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How Document Conversion Can Impact Regulatory Operations [Whitepaper]

In highly regulated industries, like Life Sciences, where a lot is dictated by regulatory authorities, compliance comes first. Organizations must get to market fast, as business needs are growing.  At the same time, regulatory pressure can slow down innovation.

Organizing processes in the most efficient way is key. Document conversion plays a big role here.

This whitepaper broadens the spectrum of document and PDF conversion in Life Sciences, and demonstrates that document conversion goes beyond excellent technology.

Successful eCTD Implementation in China: 3 Lessons Learned

China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development by the Chinese government in the last decade, the country’s global industry ranking rose from 9th largest in 2007 to 2nd in 2017. 

To help expedite the review and approval of new medicines, China will soon join other Asia Pacific countries in accepting submissions in a fully electronic eCTD format. The implementation of eCTD in Japan and Thailand highlighted many hurdles for both domestic and international biopharmaceutical companies, some of which can be avoided.

CFDA eCTD Adoption

After joining the ICH (International Conference on Harmonization) in June 2017, China’s draft eCTD guidance has now been provided by the CFDA (China Food & Drug Administration). It is time for any organisation looking to gain approval for their products in the Chinese market to prepare to take advantage of this regulatory change.

How Docker puts your rendering farm on steroids

Scalability at lower cost through containers

Container technology* has been around for a while now. The benefits are clear: scalability, rapid deployment, cost savings, simplicity. In 2019, 78% of all companies have moved workloads to containers, according to a study by DivvyCloud.

Containerization has now come to the advanced rendering space. In this blog post, we focus on the use cases and advantages of running advanced rendering on Docker. 

*Container technology is a method to package an application so it can be run, with its dependencies, isolated from other processes. A container is a package that includes everything to run an application. Containers rely less on external hardware and software and can run on any environment (Microsoft, Linux, Mac etc.)DocShifter and Container (Docker) technology for infinite scalability and easier deployment

Why should you investigate running your rendering farm on Docker?

Document conversion is a resource intensive process. Moreover, the workload is highly unpredictable in most cases. And there is typically considerable time pressure. 

Introducing DocShifter, the Switzerland of Advanced Rendering

In our previous posts, we introduced our understanding of what Advanced Rendering is.

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.

For an enterprise to get a grip on all the benefits of sharing, broad usage throughout the entire life cycle of a document and automation, various technical features must be there to make this happen. We will now focus on those technical features which a rendering system needs in order to be truly advanced.

Enter DocShifter.

 

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3 Guiding principles when implementing Advanced Rendering in Life Sciences

In our previous post, we introduced our understanding of what advanced rendering is. Why is  this more than just having the right technology in place? 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 output document right before the submission. When we introduce advanced rendering in the lifecycle of the document, then, in that moment, possibilities become endless.

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What does Advanced Rendering mean?

Advanced rendering. Compliant rendering. High fidelity or hi-fi document rendering. There are a lot of terms out there, but what do they really mean

When you’re working in a tightly-regulated industry, like Life Sciences or Banking or Insurance, compliance comes first. At the same time, business needs are growing, and there is huge pressure to get to market fast for competitive advantage. So organizing your processes in the most efficient way is key. Advanced rendering plays a big role here.

“Our ambition with this series of blogs is to

broaden the spectrum, and demonstrate that

advanced document rendering is more than just excellent technology.”

 

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6 good reasons why leading Life Sciences companies are rethinking their Document Rendering Solution

We have been converting divergent documents into a unified format such as PDF for many years now.

In knowledge-driven industries such as Life Sciences in particular, the need for standardization is highly motivated by the regulators. The introduction of the electronic Common Technical Document (eCTD) has accelerated the move from paper to electronic formats. And the International Conference on Harmonization (ICH) has further solidified this drive in its recent implementation guides for Regulated Product Submissions (RPS). Read more

What’s next after eCTD?

Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format. In the meantime, the industry is already preparing for major revisions to the way in which information is provided to the health authorities. So, what is next and how will it impact both the sponsors and health authorities alike? Read more