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Lorenz releases electronic Common Technical Document (eCTD) Publishing Module

Oct2001

05

Frankfurt Germany - October 5, 2001

Lorenz Archiv-Systeme GmbH, the premier provider of Submission Management Systems for the Life Sciences sector, today released the electronic Common Technical Document (eCTD) Publishing module for its flagship software docuBridge.com.

On August 30, 2001 Lorenz demonstrated eCTD publishing in a hearing session of the EFPIA Taskforce meeting in Brussels to reflect the technical possibilities and consistencies based on the current version of the CTD / eCTD standardization. A presentation to selected customers also showed very positive response.

"We are proud to demonstrate again our leadership in the fast adaptation of guidelines and regulations. ... while other vendors are announcing development steps, we released it," said Wolfgang Witzel, Executive Partner of Lorenz Archive Systeme GmbH. docuBridge enables industry to compile eCTD as well as regulatory authorities to review eCTD in a network environment. This is a process beyond just viewing content.

Lorenz has developed this solution benefiting from their expertise and being a part of this niche industry since 1989. docuBridge's concept is based on XML and PDF technology and during the design phase eCTD and future modifications were part of the consideration. "Even though the specification has not been finalized (e.g. DTD), we could release our software as all publishing definitions are stored in tables outside our core software. ... customers in all countries use the same software, although Module 1 varies by regions and the specification may be enhance in the future," said Akira Yamaguchi, Director Marketing of Lorenz.

docuBridge's mission is that regulatory affairs professionals can focus on their scientific tasks and leave to the software all technical aspects of publishing to paper and various electronic formats including eCTD, eNDA and eNTA. "The challenge for our team is to learn the new CTD structure and especially the revised aspect of expert reports in Module 2. ... the advantage using docuBridge is that our compilation process and DocumentumÆ customization remain unchanged," said Jˆrg Lautz, Bayer AG, Global Regulatory Affairs.

The eCTD Module is an additional brick to existing publishing suite for paper, eNDA, eNTA and PDF only. docuBridge supports dossier management - assembling, review with QA and QC, tracking and publishing - as a validated process compliant with 21 CFR Part 11. "In theory eCTD could be assembled by using off-the-shelf software, but the task would be enormous and would contradict any validated processes. ... with docuBridge a DRA professional can just presses a publishing button compliant with 21 CFR Part 11," said Detlev Rh‰sa, Senior Consultant of Lorenz.

Lorenz will continue to support all ICH interested parties through the next planned steps of the specification and implementation of guidelines.

About eCTD/CTD

The ICH’s eCTD Specification harmonizes the exchange of regulatory dossiers, in electronic format, between a submitting sponsor company and regulatory authorities of North America, Europe and Japan. The standardization will help both the pharmaceutical industry and the regulators. By providing submission content that is processed in all three regions, all parties will be able to reduce of workload and thus time to market.

The International Conference on Harmonization (ICH) - Multi-disciplinary Group 2 (M2) Expert Working Group (EWG) was established to facilitate international electronic communication by evaluating and recommending, open and non-proprietary - to the extent possible - Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the pharmaceutical companies and regulatory authorities.

Further information can be accessed under www.ifpma.org/ichectd.html, www.fda.gov/cder/m2/m2-main.htm and www.nihs.go.jp/dig/ich/m4index-e.html.