Security issues for systems used for collecting, storing and interpreting human biological data

摘要

Over recent years there has been a substantial increase in the number of computerised systems used within the healthcare industry. The system's operation and the data produced are vital in ensuring the safety and efficacy of pharmaceutical products. At the same time the healthcare industry has been battling to keep ahead of the increasing regulatory demands of computerised system validation, one integrated component of which is system security. This paper looks at the regulatory requirements for system security and considers the impact of 21 CFR Part 11 on system security methods and practices.