Author Archives: llsmarketing

LORENZ Changes Its Release Naming – Unified release naming system starting in April 2018

We are switching to a unified release naming system for all of our products, based on the calendar year.

The year-based nomenclature makes sense as LORENZ products become more and more integrated – acting as interlocking components in a single Regulatory Information Management suite. The new naming convention also follows best practice in the industry, and will help increase clarity on which version of each product is the most current – especially for customers who are using two or more LORENZ solutions in integrated environments.

For a detailed explanation of the new naming system, please click here.

To stay informed about both major and minor releases, please subscribe to Product & Service Update Announcements in your LORENZ ID.

Want to learn about Submission and Document Migration and the new challenges for established solutions? – Visit LORENZlink 2018 in April!

When eCTD was introduced more than a decade ago, the implementation of a new Submission Management Solution (SMS) was primarily a technical challenge and an adventure. Tool vendors were focused on creating submissions using documents from Document Management Solution(s) (DMS) and then publishing eCTD sequences compliant with agency specifications. From a process perspective, this was a new clean step without technical connections to the legacy – either paper or electronic submission of other formats. Project work on legacy submission migration was not needed.

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UPDATE: Current State of US FDA’s Electronic Common Technical Document (eCTD) Validation and Review Software Procurement and Implementation

We would like to provide our customers and the industry with an update on the status of LORENZ’ implementation of LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

(Please click here to read our previous blogpost including a timeline of events from 1 July 2016 – 30 May 2017.)

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docuBridge FIVE 5.11, docuBridge TWO 1.0, docuBridge ONE 2.4, drugTrack 5.3 and eValidator 5.10 released!

The October releases of docuBridge, drugTrack and eValidator are available!

Release Highlights:

With this release we are introducing docuBridge TWO, an addition to the docuBridge range geared specifically to small- to mid-sized companies with multiple users.

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International Trends in Drug Registration and Evaluation [Part 1: eCTD v3.2.2]

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.

Introduction
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.

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