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FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
In this audio brief, we unpack the practical implications of the FDA’s Final Guidance on Computer Software Assurance (CSA), issued September 2025.
The debate highlights two perspectives:
* Quality professional’s view: CSA cuts unnecessary documentation, aligns validation with patient safety risk, and supports agile manufacturing.
* Auditor’s view: CSA’s reliance on qualitative judgment, binary risk classification, and vendor dependence creates new challenges for audits, SOPs, and Part 11 compliance.
Key themes include:
* The distinction between CSA process risk vs. ISO 14971 medical device…
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