FDA Compliance White Papers

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May 19, 2013

Business of Information Technology > Business Environment > Legal Environment > Laws > Regulatory Compliance >
FDA Compliance
ALSO CALLED: FDA 21 CFR 11 DEFINITION: Compliance to FDA regulations.
FDA Compliance White Papers (View All Report Types)
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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 TOPICS: Business Process Management \| Business Process Management Software \| Cost Benefit Analysis \| Electronic Signatures \| Enterprise Applications Software \| FDA Compliance \| Manufacturing Execution Systems \| Manufacturing Industry \| Manufacturing Software \| Regulatory Compliance

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 TOPICS: Application Life-Cycle Management \| ERP \| FDA \| FDA Compliance \| Food and Beverage Industry \| Manufacturing \| Manufacturing Industry \| Manufacturing Software \| Manufacturing Systems \| Medical Software \| Pharmaceutical Industry \| SAP (Product) \| Software Implementation \| Software Selection \| Vendor Selection

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