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Designing Secure IT Environments for Pharmaceutical Clinical Trial Data Systems
- Abstract
- Pharmaceutical companies are subject to regulations imposed by the FDA (Food and Drug Administration). Key elements of these regulations are rules governing the information technology space in drug production and research organizations. The requisite security infrastructure by these systems is sufficiently different from the security requirements in other IT areas because of these FDA regulations. Security professionals need to be educated in the rules and the unique challenges they present. This paper details the relevant regulations for security professionals and the special concerns they pose. Vendor neutral infrastructure component examples are given which could be used to develop a secure environment for FDA regulated systems. By learning about the requirements placed on systems by the FDA security professionals will be better equipped to aid in vendor selection and secure system implementation. Full compliance with FDA regulations will require the work and input of many people within the pharmaceutical company.