Deployment Scenario: Regulatory Submission Planning and Management
A large pharmaceutical company with a significant submission pipeline required the ability to orchestrate all of the activities and resources associated with the submission process in order to maximize process efficiencies. The research and development organization operated across 8 sites in the US and Europe. Because of the scope of the project, the company decided to break the project into two phases. Phase 1 focused on the initial implementation of ViewPoint to support basic submission planning and management with configuration of workflows, benchmarks and reporting tools. Phase 2 focused on refining processes, integrating a document management system and a systematic deployment of the solution across the organization.
The global organization needed to get control of the submission process to improve planning and communication across functional areas and to better understand where efficiencies could be gained. This required visibility into projects and processes and the use of meaningful metrics that support management reporting and process improvement. The organization also wanted to leverage their existing investment in Documentum® and their core database store from a technology as well as a business information (meta data) perspective.
The objective of the project was to optimize regulatory processes utilizing a process management solution that supported planning and provided visibility, process control and metrics.
A 2-phase project was initiated to deploy ViewPoint to global submission process stakeholders. Phase 1 focused on enhanced planning and scheduling capabilities and the development of meaningful metrics presented in management and tactical reports.
- ViewPoint was deployed to 120 users across multiple sites in the US and Europe
- 22 regulatory business processes were managed through 6 different workflows
- 77 submission content plans (component packages) were configured
- 200 extended attributes were defined for tracking and managing submission components
- 40 training classes were conducted to support process changes
Once initial metrics collection and reporting was addressed, Phase 2 of the project was initiated to refine and simplify processes and extend the capabilities to a larger user community.
- In this phase, the user community was expanded to 260 people across 8 global sites
- ViewPoint/Documentum integration was configured and deployed to support content sharing and reuse of key meta data
- An external Regulatory Affairs database was integrated into the system and processes
The company implemented ViewPoint in a phased approach that enables the team to get immediate benefits from process management while giving them the flexibility to monitor and adjust the configuration once they had more production experience. Standard reports from ViewPoint are now used to evaluate project statuses in the context of the larger submission pipeline. Global process standards that support cross-functional processes have been rolled out and the team is now realizing the benefits of visibility and transparency in the submission planning process, control and management of submission activities and resources, greater forecasting capabilities, enhanced reporting function, and ability to effectively monitor and manage submission related issues.
The value of the solution continues to be realized as the team relies on ViewPoint for process metrics and benchmarks that add depth to management reporting vehicles. The integration of existing meta data from Documentum and a regulatory database enables a smooth flow of key business information throughout the organization.
Contact Octagon to learn more about how your organization can benefit from process visibility and control offered by ViewPoint.
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