#FINAL DRAFT SOFTWARE DEFINED SOFTWARE#
The new draft guidance does not apply to Software as a Medical Device The guidance promotes leveraging of software supplier testing and the use of automated testing tools as a means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. Software intended for automating general record-keeping that is not part of the quality record’.īoth must be validated but the risk-based approach will lead to a much less burdensome task for the supporting software. ‘ 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 that is considered to be used as a support is defined as 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 intended for automating production processes, inspection, testing, or the collection and processing of production data and Software that is considered to be used directly is defined in the guidance as Distinction between Software that is Part of the Production/Quality System and Software that Supports the Production/Quality SystemĪ 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). The focus of the new draft guidance is very much on establishing the risk associated with the intended use of the software and implementing quality assurance methods that are commensurate with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. Establish Risk Associated with the Intended Use of the Software and Use Commensurate QA Methods
Of course, the draft guidance does not contain a carte blanche for manufacturers to use software with minimal testing, the FDA reiterates that ‘ software testing alone is often insufficient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’. 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. The new 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. New: Un-scripted Testing May be an Option for Certain off-the-shelf Software The new 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 FDA has issued its long-awaited draft guidance on Software Validation.
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