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FDA Compliance

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ALSO CALLED: FDA 21 CFR 11
DEFINITION: Compliance to FDA regulations.
FDA ComplianceWhite Papers (View All Report Types)
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Beyond Compliance and the FDA Unique Device Identification Rule - How to Achieve Global Standardization
sponsored by LANSA
WHITE PAPER: This brief resource explores what the US Food and Drug Administration (FDA) Unique Device Identification (UDI) Rule is, why it was created, and how GS1 standards can be used to achieve compliance. Read on now to learn more.
Posted: 20 Feb 2014 | Published: 20 Feb 2014

LANSA

FlexNet and FDA 21 CFR Part 11
sponsored by Apriso Corporation
WHITE PAPER: Manufacturers regulated by the FDA 21 CFR Part 11 regulations understand that the integrity of manufacturing processes must be achieved and maintained in order to sustain compliance. The purpose of this document is to demonstrate that Apriso FlexNet platform and application suite can support the intent of the 21 CFR Part 11 regulatory guidelines.
Posted: 09 Mar 2011 | Published: 09 Mar 2011

Apriso Corporation

ERP Software Acquisition in an FDA Regulated Environment
sponsored by SoftBrands, Inc.
WHITE PAPER: This white paper presents a guideline to help you select an ERP system for your FDA validation. Explore a five phase software acquisition life cycle model to help you accomplish these objectives as efficiently as possible.
Posted: 06 Nov 2008 | Published: 12 Mar 2008

SoftBrands, Inc.
3 Matches
 
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