Enhanced new functionalities underscore the power of DXC publishing portfolio

Meeting eCTD obligations in multiple countries is a major priority for life sciences companies. There is a need to understand the different regional requirements and validation criteria while at the same time ensuring any solution fits with the organization’s global systems and user requirements.

With the latest version of eCTDXPress and Publisher, DXC Technology has responded to these and other needs to improve efficiency and speed up the submission process. Powerful applications and user-friendly solution, eCTDXPress and Publisher are widely embraced by publishers and with greater automation and innovation, clients have much to look forward to.

One of the most important changes to the new version of eCTDXPress and Publisher is performance upgrades to handle the creation, life cycle management and compliance validation of eCTDs/NeeS across all the regions the solution currently supports: United States, Europe, Japan, Canada, South Africa, Australia, Saudi Arabi, Thailand and the Swiss Agency for Therapeutic Products (Swissmedic).

Document type definition (DTD) and validation decoupling provides enormous benefits to companies since it is basis of a more modularized DTD/region-specific approach. With such an approach, clients can choose to incorporate or maintain only those regions that are applicable for their business. For example, some companies submit eCTDs only within the United States and can therefore ignore updates for other region without concerns. This reduces the client burden for not having to deploy all updates, and saves project times and resources.

DTD decoupling also provides flexibility in incorporating new regions and /or updates to existing regions into the product over a short period of time, which helps customer to expand their eCTD submissions to newer markets and comply with latest standard before it becomes mandatory.

Since each region is separated, clients can easily install, update, test and validate the region impacted by the changes without having to validate the whole system or other regions. This ensures greater efficiency and lower IT costs thanks to fewer upgrades, less need for system maintenance.

A second significant change to the new version is the introduction of a powerful feature for content management solution or document management solution (DMS) decoupling. What makes the decoupling capability so important and powerful is that it takes a modularized approach to DMS that allows eCTDXPress/Publisher to be integrated with any new DMS, such as OpenText, as well as to make modifications to the existing solution without having any impact on the base system.

More support, more control

The new version is also up to date in terms of platform support for 3rd party applications, for example supporting the latest version of Windows and other platforms, including the latest version of Microsoft’s .Net Framework and DFC.

The new version also provides enhanced multi-domain support, which allows administrators to create domain specific accounts. It gives more control for restricting permissions on different levels of the application and to access or make changes to submission content accordingly.

Another enhancement is the ability to include/exclude inherited metadata, which is useful when creating group submissions that involves multiple applications. This feature gives the user more control over what metadata information exists inside group applications displays.

Flexibility is a priority for businesses today, and an important feature of eCTDXPress is the ability to deploy the solution on-premise as well as on the cloud, in addition to scalability options available to meet company needs.

These changes further underscore why the DXC Publishing portfolio is the best option for life sciences companies. Already, DXC’s Regulatory Publishing Suite is used by more than 100 companies, from many of the largest pharma companies to mid-sized and smaller pharma companies as well as many major CROs.

Learn more about the DXC Publishing portfolio by requesting a meeting for an in-depth conversation and demo.


Sadia Ahmed is a product manager with DXC’s Life Sciences group.

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  1. […] Submission (RPS) 4.0. They also complimented DXC on successfully meeting its commitments in finally decoupling the Total Regulatory Solution to give users greater flexibility. For example, decoupling document type definition and validation, […]

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