P245: Streamlining Change Impact Assessment with Digital Workflow Solutions
Poster Presenter
Toshitatsu Kobayashi
Senior Regulatory Expert
Otsuka Pharmaceutical Co., Ltd. Japan
Objectives
This presentation demonstrates an example of in-house development of an application for the "Change Impact Assessment" process implemented to streamline and enhance the efficiency of the “Change Control” process.
Method
A prototype application was developed based on process interviews and workflow diagrams. Core user feedback enabled agile, iterative refinement. Effectiveness was assessed via a user survey conducted two months after the application’s implementation.
Results
The "Change Impact Assessment Application" was developed to centralize requests and results related to change impact assessments and to facilitate communication among responsible personnel. To streamline the request submission process, the system ensured completeness by requiring input for all necessary fields and highlighting mandatory items. Submissions with missing required data were restricted. Once a request was registered, an automated process retrieved the appropriate evaluators based on request attributes and sent notifications to the designated recipients.
The application optimized the assessment input process by dynamically adjusting fields according to regional requirements. Real-time visualization of request statuses—such as "before item creation," "before submission," and "submitted"—enabled efficient tracking. Users could quickly access specific requests using an advanced search function. Furthermore, the system supported consolidation of multiple regional assessments into a single file for the requester, and provided convenient search and copy functions for referencing past assessments.
A dashboard was also implemented to visualize assessment progress, helping prevent overlooked or delayed responses.
The application received highly positive feedback from users. Among 30 respondents from departments such as regulatory Chemistry, Manufacturing and Controls (CMC) team, production, quality assurance, quality control, and research, 90% reported that operational efficiency had improved or significantly improved, and 77% found the system easy to use. Open-ended feedback included comments such as: "Clearer instructions for required input fields helped avoid confusion during data entry," "The ability to specify recipients reduced the need to forward results manually," and "Quick resolution of issues was highly appreciated."
Conclusion
The internal development of the system has demonstrated significant advantages, including rapid completion of the system, cost efficiency, and enhanced user satisfaction. The close proximity between users and a developer facilitated immediate feedback collection, enabling the creation of a workflow tailored to user requirements. By incorporating user feedback from pilot testing, a highly functional system was built from scratch within four months. In addition, development costs were minimal, limited primarily to existing enterprise platform licenses and internal development time.
The system successfully addressed the specific needs of both evaluators and requesters. Evaluators benefited from features ensuring accurate data input through Quality by Design principles, maintaining consistency in evaluation outcomes via past result searches and duplication functionalities, and enabling supervisors and colleagues to receive evaluation results even if the requester was unavailable. Requesters gained functionalities such as draft-saving, pre-submission review, and pop-up hints explaining input requirements, which enhanced clarity and usability.
Survey responses further validated these benefits. Users reported improved clarity in required input fields, reducing uncertainty during data entry. The ability to set Cc recipients streamlined information sharing, minimizing the need for email forwarding. Additionally, the rapid resolution of user concerns contributed to high satisfaction levels. The overwhelmingly positive feedback indicates that the internally developed system has significantly improved operational efficiency and user experience. Moving forward, we aim to maintain and enhance the system by prioritizing usability and robustness, ensuring its long-term reliability and effectiveness.
