Deployment Scenario: Issue Lifecycle Management for Submission Components
A large, global pharmaceutical company had over 100 submission resources globally with approximately 50 resources focusing on coordination and ensuring submission components are submission-ready for regulatory processing.. Several non-scalable, non-integrated point solution technologies were being used to support the submission process. A planned increase in submission pipeline activities and an increased focus on global, simultaneous product releases created a need for a more comprehensive and integrated approach to submission management.
The current system and processes did not offer any visibility into the status of submission activities and submission issues. At any point in the process, project teams were unable to get an accurate assessment of submission readiness. Manual process to measure and track submission readiness led to inaccurate and inefficient data. Information that did exist was located in numerous spreadsheet and project plans across the organization. Issues took a long time to communicate and in some cases, issues were never tracked and often repeated. Over 80% of submission content was not received by Regulatory in a submission ready format.
This situation left submission team members in a reactive position with no ability to effectively scale operations in response to increased levels of activity.
The project was initiated to facilitate organizational awareness, understanding and compliance with the definition of “submission-ready” that the Regulatory group had developed. Receipt of quality, submission-ready documentation was seen as essential in order for the Regulatory group to scale to support the pipeline. Rework and overtime costs were major concerns as was visibility into quality parameters and frequently encountered issues. The project goal was to establish quality expectations for submission-ready components and develop a system to monitor, improve and control the process with data capture, analysis and reporting functions. This would facilitate the deployment and institutionalization of best operational practices.
Initially, ViewPoint was deployed to four functional groups within Worldwide Regulatory Operations who were responsible for the worldwide coordination of submission-ready components for submissions. Over 50 issue types were identified and configured into ViewPoint as issue categories relating to submission-ready documentation. Issues were then tracked and managed in the context of issue categories and across various global submission application types including NDAs, INDs, MAAs, BLAs and CTAs. Issues were tracked for dossier creation processes from planning through release to regulatory agencies.
In addition to issue types, key submission attributes dictated by regulatory guidance and internal process needs were also tracked. These included submission manager name, international submission leader, Regulatory liaison, project management liaison and unique product identifier.
As issues are identified earlier in the process, they are communicated and addressed more quickly directly through ViewPoint, thus alleviating the reliance on traditional communication methods such as team meetings or weekly status reports. Categorization of issues enables users to view and analyze trends within the process. Additional meta data that is tracked and managed in ViewPoint is searchable and provides insight into where issues are beginning, how they can be resolved and who is accountable to address the issue. A feedback loop for process improvement utilizes the data behind the process in providing direction to the organization so that “submission-ready” is no longer just a concept but it is built into the process.
Controlling issues from identification through resolution is a critical activity when implementing submission ready document processes across functional areas. Process owners and stakeholders now have visibility into the process and any issues that may be impacting submission dates. Resolution of issues has become more efficient and trending across issues can be analyzed to promote continuous process improvements.
The value of the solution was found in the comprehensive approach to managing issues in the context of a larger, more complex process. Advanced visibility derived from searching and reporting on issues, categories and other meta data offers early insight into potential problems and positions submission managers to drive the project rather than being driven crazy by it.
Contact Octagon to learn more about how your organization can benefit from process visibility and control offered by ViewPoint.
