LORENZ Passes GAMP 4 Audit
GUILDFORD, UNITED KINGDOM: LORENZ today announced that it’s development arm, LORENZ Bridge Software, has passed an audit following the GAMP 4 model. LORENZ Bridge Software is part of the Life Science Group and is the developer of docuBridge, the world’s leading submission management software.
The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacturing is the most widely used and internationally accepted guideli...
docuBridge Partners with Workshare for Document Authoring Process
GUILDFORD, UNITED KINGDOM: LORENZ today announced that it has entered into an agreement with Workshare, leading provider of document content productivity applications, to enhance docuBridge's ability to support the document authoring process.
"We have been faced with the challenge of bringing the authoring process closer to regulatory affairs," says Wolfgang Witzel, President & CEO of LORENZ Life Sciences. "In some companies these two tasks run in parallel for certain sections of a dos...
LORENZ publishes first details of Submission Tracking Module for docuBridge
GUILDFORD, UK - 27 Mar 2003 - LORENZ Life Sciences has announced that it is developing a Submission Tracking Module for it's state-of-the-art Submission Management System.
"The Tracking Module will provide users details of substances submitted when and where, state of renewals and much much more," says Akira Yamaguchi, VP of Product Development and Product Marketing.
LORENZ believes this to be of particular interest to biotechs, generics, phytopharmas, and veterinary life scienc...
docuBridge' capabilities enhanced with LIMS Interface
GUILDFORD, UNITED KINGDOM: LORENZ has today announced the release of it's LIMS (Laboratory Information Management System) interface to it’s world-class submission management solution, docuBridgeÆ. The interface can be configured to interact with the different LIMS available.
"The release of this important enhancement enables even more automation," says Wolfgang Witzel, President of LORENZ Life Sciences. "It also means that the return on investment on our product will rise even f...
LORENZ Chosen to Develop and Present CTD/eCTD Workshop with IIR
GUILDFORD, UNITED KINGDOM: LORENZ Life Sciences today announced that it has been chosen by one of the largest conference organisers IIR and regulatory affairs service company YES Pharmaceutical Development Services to develop and present in a series of workshops entitled "vom CTD zum eCTD" [Moving from CTD to eCTD].
The workshop is designed to teach delegates how to move from the Common Technical Document (CTD) to an electronic Common Technical Document (eCTD). The workshops will be h...
Slovenian Agency for Medicinal Products chooses docuBridge
LJUBLJANA, SLOVENIA: In a move that will equip the authority with a complete submission management solution, the Slovenian Agency for Medicinal Products has chosen docuBridgeÆ to manage and review electronic submissions - including submissions using the CTD/eCTD format. This was the result of a Europe-wide tender.
“Our aim was to improve the effectiveness in our workflow processes for today and the future, thereby shortening the time needed for a new drug submission. This include...
LORENZ Demonstrates Newest eCTD Specs at RAPS Conference
Washington D.C., USA
In a further demonstration of LORENZ’ commitment to remain at the forefront of the ICH eCTD development schedule, LORENZ has demonstrated it’s capability in already producing eCTD submissions using the September 2002 Version 3.0 specifications as supplied by the ICH. This capability was demonstrated at the Annual RAPS Conference held in Washington, D.C., on October 7th - 9th.“Our flagship product, docuBridge, is flexible enough for us to be able t...
LORENZ Announces New COO for US Operation
Baltimore - August 1st, 2002
LORENZ has announced that it has appointed Rudolph Moreno as new COO for its US operations. Rudolph Moreno brings years of experience in the pharmaceutical technical publishing industry to the company.
"We are excited to have Rudolph on board," says CEO Wolfgang Witzel. "The surge in demand for our docuBridge.com solutions has climbed dramatically in the past few months and Rudolph’s presence underlines our growth in the single largest market."...