Over the past decade, much of the attention in eCTD has gone towards publishing the eCTDs. Companies have developed processes to create more efficient electronic submission, optimizing everything up to and including the publishing in itself. However, anything that happens after the publishing process is often today still marred with many individual manual steps.
Validate: When do I begin validating, do I know which profile to choose and is it up-to-date? What happens once validation is done? Is it an active or a passive process, i.e., do I need to wait for something to complete and monitor it myself, or am I being informed? Just this one step raises many questions.
Dispatch: The arrival of agency gateways will help remove the very manual process of burning media, creating labels and performing a quality control. However, all portals operate differently. They use different technologies, have different acknowledgement methodologies and different upload methodologies. Do I know how each portal operates and where does my acknowledgement go to? What should that trigger? How and when do I update my tracking system to record that new status?
Archive: Once the submission has been received, what do my company policies say about archiving? Is the submission loaded into the EDMS? Is it physically copied onto another local national archive folder located in the country of submission? Is an online backup made? Do I manually copy and paste the submission content, and how do I verify that really everything has been copied? What happens to the submission that acted as the source of the upload to the portal?
These are all questions that have come up again and again - by both industry and agency. LORENZ has been working over the past year to find solutions to many of these manual tasks, helping to automate many of these processes and also bring together and integrate other third-party systems that may be affected somewhere in the process downstream.