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.

6 Valuable Tips: Why should you convert to PDF?

Most companies are not demanding when it comes to the file formats they use. They just use the most common file formats as the logical extension of their software tools. The best example is the Microsoft Office package. Although Word is a good program for word processing, text editing and file formatting, a Word-file (.docx) is not the best suited file format for storage, archiving, sending sensitive and private data, and internet sharing purposes. Read more

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. 

5-Step Automation: Reduce Risks in Correspondence Tracking

Life Sciences organizations deal with external parties and health authorities on a regular basis. Given the amount of information, tracking all that communication is very challenging and burdensome. 

“An essential part of any complete RIM platform

is the ability to plan and track all regulatory

activities that an organization needs to undertake.”

These activities are often initiated by a request from a health authority for more information, It is critical that these requests are traceable alongside the tracked regulatory activities in the RIM platform.

Read more

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.”

 

Read more

What are the key disruptors for Life Sciences?

Every industry goes through changes over time and the Life Sciences industry is no exception. But not every change is significant. With so many buzzwords and jargon being thrown around, sometimes it’s hard to wade through the noise and get to the heart of it all.

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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