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Pharmaceutical Engineering

Every Cloud has a GxP lining

Published on March 24, 2016 in 21 CFR 11/CSV Engineering/CSV Ireland/Food and Drug Administration (FDA)/GxP Clouds/Odyssey Validation Consultants/Pharmaceutical Engineering/Regulations-Standards by admin

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

Published on March 22, 2016 in 21 CFR 11/CSV Engineering/CSV Ireland/Food and Drug Administration (FDA)/GxP Clouds/Odyssey Validation Consultants/Pharmaceutical Engineering/Regulations-Standards by admin

Validating GxP Services in the Cloud - FDA Concerns — Validating GxP Services in the Cloud – FDA Concerns

Ireland, March 22nd 2016:

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

Published on March 18, 2016 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 admin

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

How Computer System Validation (CSV) Service evolved?

Published on March 8, 2016 in Automation/CSV Engineering/CSV Ireland/Food and Drug Administration (FDA)/Lab/Odyssey Validation Consultants/Pharmaceutical Engineering by admin

Naas Ireland, 8th March 2016: HCL Technologies has published their whitepaper called Computer System Validation

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