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PP09-68: A Large Company's Submission Planner: A Tool to Plan, Resource, and Process Publishing Projects via Automated Workflows/Data Analytics

Poster Presenter

Kousalya Vaddempudi

Manager, Regulatory Operations
Otsuka Pharmaceuticals
United States

Objectives

To develop an automated tool that assists in planning and tracking of publishing tasks through different stages from initial request to final approval and archival via automatic workflows/notifications while capturing audit trail and generating metrics for analytics, budget, and workload management.

Method

Otsuka Global Regulatory Affairs has developed a submission planner (GRASP) that centralizes publishing tasks to optimize processes/enables monitoring capabilities to support automated notifications, cost-effective 24hr global resourcing, forecasting, task-tracking execution, portfolio transparency.

Results

GRASP is integral to planning and management of submission and document publishing processes on a global scale using centralization and automation. This enables more effective communication and resourcing while ensuring continuous workflow across multiple time zones. Centralization provides a single point to manage multiple tasks including initiating and accessing publishing requests; reviewing project information such as resources assigned, functional area (FA) contacts, publishing instructions, and timelines; logging issues; tracking and updating workflow status; and creating notifications. GRASP is linked to a Master Application List (MAL) that catalogues all Otsuka products with relevant information and respective regional and global points of contact. Automation allows collection of subsets of metadata to employ in project planning, scheduling, oversight, metric reporting, and other regulatory activities. GRASP covers publishing activities beginning with planning a request and continuing through preparation of publishing deliverable, quality checks, approval, submission, and archival. The request entry process is simplified by submission of an online form with information provided by the user or inherited from MAL which helps the publishing team with instructions, prioritization, forecasting, and assigned FA leads. Depending on start and end dates and type of publishing deliverable, the system can calculate publishing time required and inform the requestor whether the timeline is sufficient. GRASP eliminates a need to manually compose and send emails to team members on status changes, task notifications, and new or updated publishing instructions. Automated targeted notifications are triggered throughout the publishing process whenever there are key changes in status of a publishing deliverable to keep the publishing team and requestor informed of real time progress. Users can also actively search for status of pending tasks by selecting various views in GRASP.

Conclusion

GRASP is an Otsuka global submission tracking and management SharePoint-based tool that promotes quality, efficiency, and accountability in the publishing process through time-saving features such as automated notifications, tracking and updating workflows, capturing audit trails, and data analytics. GRASP can be utilized with minimal training by publishers/FA representatives. Use of GRASP closes gaps in workflow created by time zone differences that impact scheduling and thus allows a seamless transfer of work across regions. GRASP allows simultaneous visibility of high-volume and nature of publishing deliverables to for portfolio management and corporate transparency. GRASP triggers auto-notifications to publishers and QC reviewers, issues auto-reminders of critical dates, and provides status updates for pending and completed tasks. Auto-notifications contain direct links to GRASP records for easy navigation and can be convenient to check on status of submission activity. Attachments can be added to GRASP records, such as an inventory list of submission documents, publishing instructions, QC checklists, and issue logs. Other features of GRASP include the ability to create an audit trail, collect data on various metrics, and generate reports that can be applied for system and process improvements. Recent additions to GRASP include support for document level publishing. Dashboard enhancements have been made to simplify assignments of publishing tasks/monitor usage. Information from MAL can now be applied to projects from multiple FAs to initiate workflows and generate queries for submission-related activities. Future GRASP enhancements will include automatic resourcing for the newly received publishing requests, mechanism to store region-specific metadata for eCTD deliverables, support for a distinct publishing calendar, and interactive metric reporting.The authors wish to acknowledge Bill Hannon for his initial initiative and support in making this system a reality