PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermittently. Staff members from processes and subsystems within the organization that interface with PMS (CAPA improvements, clinical evaluations, design & development, vigilance, risk management) are expecting a level of analysis on PMS data for their own decision-making purposes. PMS knowledge management is a proactive, cross-functional process that includes holistic planning, checking, action, and standardization of creation, usage, sharing, and maintenance of organizational PMS data. Data sources are key to this. They can be classified as active or passive sources, and a good PMS data collection system should use a combination of the two.
This whitepaper provides examples of data sources which can be considered by the organization for the purpose of post-market surveillance.