Posts

DocShifter powers the document conversion solution in Generis new CARA cloud offering

We are happy to announce our DocShifter software will be the default enterprise document conversion solution in Generis’ new CARA cloud offering. The integration will further strengthen the bond between organizations and allows the new CARA to serve a larger range of clients with expanded document conversion functionalities.

New CARA cloud offering provides an enterprise content and information platform, able to store and manage data both in CARA as well as that stored in a range of other repositories.  While the integration has been available for classic CARA for some time, it will now be the default option for the New CARA Cloud platform for customers requiring rendering meeting a range of complex requirements of regulated industries. 

DocShifter solution automates any-to-any conversions with support for 300 input and output formats. The speed, scalability and connectivity with all DMS & RIM systems make DocShifter technology an essential for Life Sciences organizations that deal with complex content and document conversion requirements. 

 “With the integration of DocShifter as the default document conversion solution into the new CARA, we are able deliver our promise even better: drastically speeding up and simplifying the complex process of content and document conversion. DocShifter’s document conversion capabilities, combined with new CARA, are able to answer the complex requirements of highly regulated industries,” states Geert van Peteghem, CEO of DocShifter. 

“We already support many joint customers who have advanced document conversion requirements met by the integration of DocShifter with CARA,” said James Kelleher CEO of Generis. “We are now happy to be able to offer this on a pre-built package with New CARA on our cloud for such customers.”

About DocShifter

DocShifter

DocShifter was created in 2007 to respond to the need for easy and fast content conversion in highly regulated environments. Customers can be found worldwide in Life Sciences, Public Sector, Engineering, Banking & Insurance. The company is headquartered in Ghent, Belgium.

At DocShifter, we believe that relevant digital content should never become obsolete. Unstructured information needs to be kept in a readable and searchable format, for generations to come. In our fast-paced digital world, standards appear and disappear. Transforming all this digital content, in whatever shape or form is our goal. To ensure your information continues to provide value.

About Generis 

Generis is a global leader in content and information management systems, specialising in proven solutions for regulated industries. Established in 1997 as a consultancy group, Generis has since grown and developed alongside its flagship product CARA. Our mission is to provide a platform which is highly configurable and user friendly; a dedicated team works hard to guarantee customer satisfaction. Currently counting over 450,000 users across numerous industries worldwide, including 8 of the 10 largest Life Science companies, CARA continues to progress to become the answer for end-to-end data management. 

To find out more visit: www.generiscorp.com

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.

About the author – Paul Ireland 

Paul Ireland - VP Life Sciences - DocShifter

20+ years in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Industry and commercial experience in delivering Content Rendering, Regulatory Information Management, Submission and Report-level Publishing, and Electronic Document Management solutions. 

Can I help you with anything? Let’s jump on a brief call discuss more.

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.

 

Read more

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.

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.

Read more

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

DACHS Biosciences and DocShifter Partner Up to Help Life Sciences Companies Deal With the Growing Challenges Around Advanced Document Conversion

We are proud to announce our new partnership with DACHS to meet the growing needs for document conversion & enrichment in the Life Sciences industry.  The advanced content conversion capabilities of DocShifter combined with the expertise of DACHS in document management for pharmaceutical companies make a powerful strategic alliance.  Read more

Events

Nothing Found

Sorry, no posts matched your criteria