The April releases of docuBridge, drugTrack and eValidator are available!
What´s new in docuBridge? Several improvements come with release 19.1. An enhanced page scaling option for print and other publishing formats is available, and more granular permission settings for administrators. Continue reading
The October releases of docuBridge, drugTrack and eValidator are available!
What´s new in docuBridge? Multiple user-friendly improvements have been made. Configurable column layout settings in the submission Continue reading
RAPS has once again chosen LORENZ to support their intermediate-level training workshops. Here, our LORENZ docuBridge solution is being used to illustrate the eCTD concept in detail, with discussions led by members of LORENZ and Mentara Inc.. The collaboration on RAPS workshops has been running since 2012.
Two of the three planned workshops in 2018 have already been completed; the first in San Diego, CA during April and the second in July in Rockville, MD. San Diego will also host the third training this coming November.
Several anti-virus scanning programs have started to report that installed docuBridge software (version 5.10 or higher) is infected with viruses or malware. Please note: Continue reading
Good news for our docuBridge ONE customers! The eLearning experience for our workstation solution docuBridge ONE has been completely reworked: it is now interactive and still absolutely free of charge for all docuBridge ONE customers!
The LORENZ implementation team was on-site at the USFDA headquarters in Silver Spring, Maryland between April 30 and May 4, 2018, to discuss the implementation process and to begin the training of agency personnel in LORENZ solutions within its RIM portfolio.
Today Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ, starts with a series of articles talking about international trends in Drug Registration and Evaluation. He will provide an update on some selected topics in electronic submissions and some insight into how LORENZ will deal with these evolving regulatory requirements.
Regulatory authorities around the world continue to adopt internationally recognized data standards in an effort to improve the efficiency of their work environments and processes. The most commonly discussed data standards are the Electronic Common Technical Document (eCTD); International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP); Health Level 7 (HL7) Structured Product Labeling (SPL)-based standards for the transmission of product data, including IDMP; and Clinical Data Interchange Standards Consortium (CDISC)-based standards for both clinical and non-clinical study data.