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News on Computer System Validation across all GxP assets. Partner of Odyssey Validation Consultants

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Regulations-Standards

Every Cloud has a GxP lining

in 21 CFR 11/CSV Engineering/CSV Ireland/Food and Drug Administration (FDA)/GxP Clouds/Odyssey Validation Consultants/Pharmaceutical Engineering/Regulations-Standards by
FDA GxP Cloud Computing Regulations
Every Cloud has a GxP Lining

Ireland, March 24th 2016: One of the challenges faced by traditionally conservative regulated industry is how to squeeze

Validating GxP Services in the Cloud – FDA Concerns

in 21 CFR 11/CSV Engineering/CSV Ireland/Food and Drug Administration (FDA)/GxP Clouds/Odyssey Validation Consultants/Pharmaceutical Engineering/Regulations-Standards by
Validating GxP Services in the Cloud - FDA Concerns
Validating GxP Services in the Cloud – FDA Concerns

Ireland, March 22nd 2016:

Partially cloudy with a chance of an FDA audit

in 21 CFR 820/CSV Engineering/CSV Ireland/Food and Drug Administration (FDA)/GxP Clouds/Odyssey Validation Consultants/Regulations-Standards by

GxP Cloud Validation: Particially Cloudy with a Chance of an FDA Audit

Ireland, March 21st 2016:

Engineer at Odyssey Validation Consultant Researching CSV with National University of Ireland

in 21 CFR 820/CSV Engineering/CSV Ireland/Food and Drug Administration (FDA)/National University of Ireland/NUIG/Odyssey Validation Consultants/Pharmaceutical Engineering/Regulations-Standards by
FDA Guidance on post market validation of medical devices
A hacker can easily take control of many types of medical device using specialized Linux tools. FDA has issued new guidance on post-market validation

Kildare, 18th March 2016: The US Food and Drug Administration, from time to time, issue guidance on important industry

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