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PathO3Gen Solutions

21 CFR §211.28 · EU GMP Annex 1 · ISO 14644

Ready when you are

Self-assess your facility's floor and entryway contamination controls — SOPs, gowning, footwear hygiene, and environmental monitoring — against FDA, EU GMP, and ISO expectations.

You'll review 27 controls, one screen at a time. For each, indicate whether it's already in place at your site. When you're done, you'll get a 100-point readiness score and a summary of gaps to address.

Duration

~20 min

Sections

5

Max score

100 pts

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Score 0/100 · HIGH risk — personalized PDF + checklist