Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part I

In Part I of this article, the author reviews regulatory requirements that apply to computer resources and current technologies that can be used to mitigate threats to and vulnerabilities in computer resources. Part II will review how current technologies can apply to the security requirements contained in 21 CFR Part 11, Electronic Records, Electronic Signatures, Final Rule. Computer security is used to regulate and record access to computer resources as well as manage records residing in a computer. It is one of the main factors to consider when implementing environments that will manage electronic records (hereafter referred to as records) set forth in FDA regulations or electronic records submitted in compliance with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. FDA defines electronic records as any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created,modified, maintained, archived, retrieved, or distributed by a computer system. One example is the submission to FDA of records and reports supporting the safety and efficacy of new human and animal drugs, biologics, medical devices, and certain food and color additives. The advantage of using computer technologies supporting electronic submissions and inspections is that FDA can review and analyze this information with automated tools, thereby reducing the review time.

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