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.
The USFDA is introducing docuBridge, eValidator, and Automator at CDER and CBER – the centers responsible for regulatory oversight of drugs and biological products in the United States. Our team is working to ensure that all software runs flawlessly while meeting all functional and non-functional requirements – and above all to make the changeover happen smoothly. The April-May working session also included a hands-on training in docuBridge as an eCTD review tool.
The next phase in the software launch will be the migration of the USFDA’s legacy eCTD sequences into LORENZ systems. To our knowledge, this will be one of the biggest migrations of records ever done! Over the next several months, more than 1.3 million legacy eCTD sequences from the USFDA will be migrated into docuBridge and made available to USFDA reviewers.
During this period, incoming submissions will also have to be directly transmitted to the new solution, with LORENZ Automator managing the automated validation and import of these inbound submissions. This will enable a seamless, fluid transition from the USFDA’s legacy systems to the LORENZ software. Specifications for the migration and the automated processing of incoming submissions were also discussed in detail during the April-May visit.
We will be working diligently with the USFDA over the next few months to complete the changeover. This will include further rounds of training for the USFDA’s review community in how to use LORENZ tools for eCTD submission review.
Questions regarding the USFDA-LORENZ contract or LORENZ’ partnerships with other leading regulatory authorities around the world can be directed to Jared Lantzy, Manager of Global Regulatory Agencies and Processes. Questions can also be submitted to LORENZ directly and will be routed appropriately.