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By John Lafferty
Article updated: March 2025
Read time: 3 minutes
The draft guidance entitled Computer Software Assurance for Production and Quality System Software (dated 13th September 2022) represents a new dawn for software validation in a manufacturing environment.
The guidance is risk-based, as one would expect, but for the first time, it guides that un-scripted testing may be an option for assurance of certain commercial off-the-shelf software (COTS) including certain uses of spreadsheets. This news will come as music to the ears of many Pharmaceutical and Medical Device manufacturers around the world who have long questioned the added value of some of the documentation required for testing COTS systems up to now.
Of course, the draft guidance does not contain a carte blanche for manufacturers to use software with minimal testing, the FDA reiterates that ‘software testing alone is often insufficient to establish confidence that the software is fit for its intended use’ and that the focus should be on ‘on preventing the introduction of defects into the software development process’ and the ‘use of a risk-based approach for establishing confidence that software is fit for its intended use’.
The focus of the draft guidance is very much on establishing the risk associated with the intended use of the software and implementing quality assurance methods that are commensurate with that intended use.
A distinction is drawn for the first time between software that it used directly as part of production or the quality system (which is considered a higher risk) and software that supports production or the quality system (which is considered a lower risk).
Software that is considered to be used directly is defined in the guidance as;
‘Software intended for automating production processes, inspection, testing, or the collection and processing of production data; and
Software intended for automating quality system processes, collection and processing of quality system data, or maintaining a quality record established under the Quality System regulation’.
Software that is considered to be used as a support is defined as;
‘Software intended for use as development tools that test or monitor software systems or that automate testing activities for the software used as part of production or the quality system, such as those used for developing and running scripts; and
Software intended for automating general record-keeping that is not part of the quality record’.
Both must be validated but the risk-based approach will lead to a much less burdensome task for the supporting software. The guidance promotes leveraging of software supplier testing and the use of automated testing tools as a means of reducing validation effort whilst continuing to assure software quality and avoid risk.
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It must be noted that the draft guidance does not apply to Software as a Medical Device (SaMD) and that when it becomes Final Guidance, it will replace only Section 6 (‘Validation of Automated Process Equipment and Quality System Software’) of the FDA’s existing guidance – General Principles of Software Validation.
This draft guidance will require careful reading to fully digest its implications. Although the comment period for this has passed, the FDA are allowing late comments, and we look forward to seeing it published as a final guidance in the future. At SQT Training Ltd. we will be exploring the implications of this draft guidance as part of our Software Validation Training course and embedding the final guidance in the core of course materials.
Let me know in the comments what your thoughts are on this draft guidance.
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