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Is the Endosafe software validated?

endosafe Software validated
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Is the Endosafe software validated?

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Our EndoScan-V is the first endotoxin-specific software that addresses the 21 CFR Part 11 requirement for validation. Both EndoScan-V and the BioTrend 3.0b database trending software are verified and validated consistent with USFDA and CE mark requirements and comply with CFR 820.30.

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