When considering software process and software validation requirements for “product software” versus “tool software,” it can be very confusing and challenging. We have created a job aid that can help facilitate the discussion of the differences between the two. Product software runs as part of the product, whereas tool software is software running a tool used for development (e.g., compiler) or testing tools (e.g., static analyzer).
The QSR which requires that “when computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol.” ISO 13485 § 4.1.6 requires validation of quality system software.
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SoftwareCPR-ProductVsToolSoftware-JobAid-2021
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