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December 15, 2003 | Using or developing open-source software (OSS) raises special questions for biotech organizations. Despite the fact that many answers won't be definitive, organizations should ask the following questions anyway:

  • Will OSS deliver tools of the required reliability, quality, and robustness?

  • When the software is involved in a regulated process, will the use of OSS help or hinder compliance approval?

  • Can the OSS community provide the continuity in vertical products as they have for horizontal products such as the Linux operating system?

  • How long will the developer community continue to show interest in supporting a particular product, and will it be long enough? Or will the community move on to new products and orphan older ones?

  • Will the available OSS tools and products provide the degree of reliable security needed for patient and research records?

  • How is security ensured for OSS products that are constantly evolving?

  • How do users control the updating of products?

  • How can a company delivering a product under an open-source license continue to support its users when they keep modifying the software?

  • Can the widespread use of open-source software in academic research be carried over to the corporate research environment? If not, does that mean universities will encounter difficulties licensing their research tools?

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