Hardware Podcasts

185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder

Let's Combinate · 23 Apr 2025 · 25m

What this episode covers

Aaron Snyder, founder of Quality Systems Explained and former VP of QA at Allotex and Fresenius Kabi, explains the hierarchy of quality documentation, distinguishing between policies, SOPs, and work instructions. He emphasizes that while SOPs define 'what' to do, work instructions must detail 'how' to do it, particularly when using electronic systems like MasterControl or TrackWise. Snyder highlights the critical role of RACI matrices in defining clear roles and responsibilities to prevent ambiguity and ensure accountability in regulated environments.

Most relevant to

established companies

Topics

Mentioned

Companies
Allotex, Fresenius Kabi
Tools
MasterControl, TrackWise, ETQ, Agile, Arena, RACI Matrix
Also
Quality Systems Explained, ISO 10013

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