Legacy Refresh

What to do with Legacy Data?

Many companies sit on a big pile of old data or use outdated systems to manage certain company information. These legacy data and applications might still be valuable to the organization, but their inefficiency, poor usability and high maintenance cost do not weigh up against the benefits. To get the most out of your legacy data you should convert these files to new file formats to keep them accessible, readable and searchable in the long term. Read more

Key Disruptors Life Sciences

What are the key disruptors for Life Sciences in 2018?

2017 has been rife with activity in the Life Sciences sphere. But now, 2018 has begun, and, as would be customary, it is time to move on from the past, and to look forward to what this next year will bring. 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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Award Best Product

DocShifter nominated for two Data News Awards for Excellence

DocShifter has been selected as a nominee for two of the Data News Awards for Excellence. The Data News Awards for Excellence is a yearly event put on by Data News, a reference ICT publication and platform in Belgium. The Data News Awards for Excellence rewards companies, products and individuals from fourteen different categories within the ICT sector.

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eCTD

What’s next after eCTD?

As life sciences companies face enormous challenges to comply to the increasingly complex regulatory environment and more and more of the world adopts the fully electronic eCTD submission format, 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

News

DocShifter starts 2018 with a new CEO and a clear focus on growth.

In December 2017, Geert Van Peteghem was appointed CEO of DocShifter. At the same time, the Ghent based company introduced its new future strategy for marketing its document transformation platform on a wider scale. By doing so, the company firmly intends to fly out from under the wings of the company where it all started, Docbyte.

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eCTD Life Sciences

Frequently asked questions on the eCTD format (Part 2)

The electronic submission requirements (CDER/CBER) will apply to the following types of submissions: Read more

eCTD Life Sciences

Frequently asked questions on the eCTD format (Part 1)

A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for: Read more

eCTD Triangle and Modules

A closer look into the eCTD triangle and its modules

CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.

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DocShifter 6.1

Check out the new features and improvements of DocShifter 6.1

We are pleased to announce the release of DocShifter 6.1. This updated version contains a slew of powerful new features. Read on to learn more about the upgraded DocShifter enterprise content transformation platform.

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Challenges Life Sciences Compliance

6 unique challenges of life sciences compliance

In the highly regulated life sciences and biotech industry, companies are forced to comply with countless rules and regulations across all business aspects. The myriad and complexity of regulatory requirements has increased sufficiently over the last few years and is expected to grow even more in the future. Using an efficient quality management system helps companies to simplify ICH-, FDA- and ISO- compliance. Read more