What is LORENZ Automator?
The Automator supports the automation of pre- and post-publishing tasks. These are tasks that - today - are typically performed manually.
The process for generating new drug submissions or a change in a submission ends with the validation of the dossier against the agency requirements and its subsequent publishing in eCTD or NeeS format.
However, there are still a number of post publishing activities to be completed before the submission arrives at the target agency and is finally archived internally. The introduction of submission gateways for various regions and countries means that more and more dossiers are being sent electronically - and not as CDs or DVDs - which presents an additional challenge, but equally a new opportunity.
Depending on the submission gateway and the complexity of internal processes, companies may have to perform upwards of 50 manual steps for each individual submission before all post publishing and archiving tasks are completed. Large pharmaceutical companies may need to do this for several thousand submissions a year.
Manual post publishing and archiving activities are time consuming, error-prone and costly. For that reason leading pharmaceutical companies and regulatory agencies are asking LORENZ to automate this process using the LORENZ Automator solution.
The Solution - A Case Study
The LORENZ Automator uses a custom-designed developer toolkit, in which the customer´s post publishing processes (or in the case of a regulatory agency, pre-review processes) can easily be modeled. For most process steps, there is already a pre-built software component available covering the functionality. In some cases, components may have to be configured. For a very few specific requirements, new components have to be built.
With the Workflow Editor, these components are orchestrated into a profile, which represents the entire business process for a certain activity such as uploading a submission to a gateway.
In one example, five Automator solutions have been built for one customer:
- Gateway Upload for EMA, FDA and Health Canada
- Archiving for the US and Canada
The Benefits: Significant benefits are already visible after the first phase implementation of this particular customer:
- Manual working steps are reduced to almost zero
- Time savings in post publishing and archiving in this first phase are already more than 500 hours per year
- There is less interruption of the daily work (e.g. waiting for ACK messages)
- Less training is required for newcomers
- Quality improvements (less typos and other manual errors)
The deployment of the LORENZ Automator solution at this customer has been received so positively, that further automation projects are planned.