Dossplorer™ Xchange Bot
RPA for Regulatory Affairs
An example of the many opportunities where robotic process automation eases the life of RA professionals
The Dossplorer Xchange bot automates the process of making newly (re) published dossiers and sequences visible in Dossplorer and is a great example of RPA for Regulatory Affairs. Dossplorer™ is an eCTD viewer developed by Qdossier that allows you to share, view, and review regulatory dossiers in eCTD, NeeS, and other dossier formats from any region or country.
Many companies experience loss of time during the publishing process when sharing draft sequences for review. First, the published output has to be zipped, password protected and is often shared via (slow) exchange portals. The sequences must then be downloaded, unzipped and reviewed. After the review is performed, the steps are repeated multiple times (for every review round!), resulting in loss of valuable time. Also, authors and reviewers must communicate at each step to verify the document status, which is another time-consuming process. This scenario is a perfect example where RPA for Regulatory Affairs can ease the life of RA professionals.
Dossplorer Xcange bot eliminates manual steps in the exchange of regulatory dossiers
With Dossplorer and the Dossplorer Xchange Bot, almost all manual exchange steps are eliminated through RPA. The review of regulatory dossiers can be done through Dossplorer with an extensive comment function, making communicating outside of the application unnecessary. Manual import of dossiers and sequences is eliminated with the automated import function, and the Dossplorer Xchange Bot takes over manual steps in sharing dossiers and sequences between the authors and reviewers.
As a member of the publishing team, you only need to copy the published sequence or dossier to a sFTP site then the Dossplorer Xchange Bot does the work. The bot unzips and copies the new sequence to the correct location in the dossier repository where Dossplorer’s automatic importer will discover the new sequence. After the import is completed, a notification is sent to a (configurable) distribution list.
Dossplorer is accessible via the web browser, allowing for review at any time and any place. Feedback can be given within Dossplorer and links to exact locations can be shared. If re‑publishing is needed, the only thing the publishing team needs to do is copy the (re)published sequence to the sFTP. Dossplorer will discover the new version of the same sequence and replace the existing.
Security and Quality Assurance
Data Transfer is done using secure file transfer protocol (sFTP) to enhance security even more. The Dossplorer Xchange Bot can handle password-protected zip files as well.
The Dossplorer Xchange Bot, along with its automatic import feature and comment function, has been fully validated through Operational and Performance Qualification testing. This validation process includes user stories, acceptance criteria, validation scripts, test results, and a final validation evaluation.
“Unlock and explore the true value of your regulatory dossiers in a safe and secure, web-based eCTD viewer”