LORENZ docuBridge, eValidator, and Automator making their debut at the USFDA

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.
Continue reading

International Trends in Drug Registration and Evaluation [Part 2: eCTD v4.0]

Our last blog post on this topic covered eCTD v3.2.2 and its advantages over paper or non-eCTD electronic submissions. The main selling points of v3.2.2 are its reliable presentation of information to reviewers, the level of flexibility for national authorities, the metadata for automated processing, the life cycle information on documents, and the reuse of information.

Introduction
In this second part of our series about international trends in drug registration we dive into the improvements from eCTD v4.0 over eCTD v3.2.2.

Continue reading

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.

Continue reading

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.)

Continue reading