USA – FDA drafts guidance on device production and quality system software assurance

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production.

FDA said the draft guidance is a document for industry and agency staff to evaluate computer software with “a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate.” Additionally, the document outlines how stakeholders can validate the software and determine it is being used appropriately.

The guidance will eventually be a supplement to the “General Principles of Software Validation” final guidance published in January 2002 and take the place of Section 6 of that guidance, which focuses on validation of automated process equipment and quality system software…