FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
Let's Talk Risk! Podcast
- Published
- October 6, 2025
- Duration
- 16:05
- Summary source
- description
- Last updated
- Jul 5, 2026
Discusses In this audio brief, we unpack the practical implications of the FDA’s Final Guidance on Computer So…
Summary
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 reli…
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Show notes
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