#Open source software categories software#
The large majority of OSS today would be classified as GAMP Category 1 software (i.e., embedded software components, libraries, development tools, and operating systems). Specifically, we will cover the importance of recognizing when an organization is relying on OSS and the benefits and risks this brings from a GAMP Category 5 perspective (see Figure 1). This article aims to refresh Pharmaceutical Engineering® readers on the topic and build upon the foundation set in the 2010 article by highlighting several areas that have advanced since the publication of that article. While important to understand, the primary concern from a GxP perspective is the development and maintenance of this software, and we will simply refer to it as OSS in this article.
#Open source software categories free#
OSS is sometimes referred to as free/libre/open-source software (FLOSS) or free and open source software (FOSS), which attempts to distinguish between the values behind developing OSS and the licensing models for distributing it. In the May-June 2010 issue of Pharmaceutical Engineering®, the article “Guide for Using Open Source Software (OSS) in Regulated Industries Based on GAMP” detailed the various support models for maintaining a GxP environment where OSS is used.
When relying on OSS within a regulated computerized system, it is important to understand the method in which that software is developed and maintained so that critical thinking can be applied when determining the level of risk and mitigation strategies.
Whether it is the use of well-known operating platforms like Linux or statistical analysis tools such as R or leveraging available JavaScript libraries to build custom applications, OSS has permeated most enter-prises, including pharmaceutical/biopharmaceutical companies. Reliance on OSS has become prolific across today’s information technology (IT) environments.
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