医疗器械的数据完整性

The Data Integrity for Medical Device

数据完整性是当前医疗器械监管的重点,其本质就是从企业业务数据层面出发,通过观察业务数据本身的详尽程度、数据与数据之间的逻辑关系以及数据安全受控状态来判断其对应的业务执行的真实情况。文章从各国监管机构对数据完整性的定义出发,分析其监管本质,企业实际现状以及其背后的原因,并最终找出企业因对方案。

Recently the data integrity is a hot regulation requirement for the medical device manufacturer. The requirement is try to find out the reality status of manufacturer through the transaction data analysis, include the detail level of the data, the logic consistency of the related transaction data and safety control of the data（Not easy to be tampered）. We will analysis the root cause of the failure of regulation, and provide the correct action list need to be done by medical device manufacturer to support regulation compliance.