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Enterprise Solutions for Validation

Improving Speed and Process in Post Publishing

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.

Solution 1: LORENZ eValidator Enterprise to Support Server-Side Validation

Combined with the powerful webPanel, the eValidator Enterprise supports the process of automating many tasks post-publishing. The eValidator Enterprise can identify when a publishing process has completed and can automatically launch the validation process. It can also identify which profile should be used based on pre-defined business rules. Users are kept up-to-date through a browser-based App, and are even notified automatically should there be a status change.

Server-side validation has two additional advantages:
Data security: Users no longer need access to the original submission content and can monitor and control the entire process remotely through the browser. This means users cannot accidentally change submission content or structure after validation.
Central maintenance: Updating the validation engine is done centrally at one location, thus users can be sure they are using the latest validation profiles as issued by the various regions. No longer do updates have to be performed manually, and possibly on multiple workstations.

An additional advantage of the Enterprise package is the possibility of obtaining extended regional Good Regulatory Practices validation profiles.

These profiles go beyond the requirements of the regulators that often only look at the current submission unit or sequences and the previous one. Deep life-cycle scans and additional PDF analysis can help avoid problems further down the line, when making corrections to submission units can become even more expensive. The proof lies with Health Canada: they looked at our Good Regulatory Practice profile for Canada and found the added checks so compelling, that they have rolled them into their standard requirements!

Solution 2: LORENZ Automator to Support Integration

The Automator is an engine that runs in the background and acts as a central task management system. Scripting allows for maximum flexibility in developing and coding the different tasks. These tasks can look very different from organization to organization and often follows existing manual SOPs.

Examples include copying submissions to another file server and verifying the result, uploading submissions to gateways and processing the gateway feedback, as well as updating third-party systems such as tracking or ERP systems. Additionally, through the integration with the webPanel, users have access to all types of information and are able to control and resume processes as well.