I’m so tired of #Homeopathabullshit….
I’m not a big fan of using checklists during audits, but it is always good to see which ones are being used by the regulators to better understand their thinking and priorities. This one from Japan came up during the quarterly Society of Quality Assurance CVIC (Computer Validation Initiative Committee) on which I sit.
PMDA Checlist CSV
The FDA has recently updated their published 483 inspection results here. This is really a great resource as it breaks the findings down by regulation and how often it was cited. The link is to the 2010 483 that I stumbled upon. The parent site has multiple years and in sortable formats:
As a break from writing, I finished the first electronic version of my CSV Audit Mindmap. The intent is for it to be a mental tickler during an audit. Rather than 10-20 pages of checklists, this would be a visual layout of related topics that fit on 1 or 2 pages (or more if you like). Click the link to look at a pdf version…and be sure to let me what you think.
CSV Audit Mindmap