FDA 21 CFR 11 White Papers, Software Downloads, Definition and Webcasts

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May 19, 2013

Business of Information Technology > Business Environment > Legal Environment > Laws > Regulatory Compliance >
FDA 21 CFR 11

FDA 21 CFR 11 Reports

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

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

Case Study from IDC: Speeding the Cure: Kalypsys Deploys Xerox DocuShare CPX to Accelerate Drug Development sponsored by Xerox DocuShare CASE STUDY: Learn how Kalypsis, a clinical stage pharmaceutical company, is leveraging Xerox DocuShare Enterprise Content Management to control content for regulatory operations and clinical trials. Posted: 08 May 2008 \| Published: 01 Jan 2007 TOPICS: Business Process Management \| Content Management \| Content Management Software \| Content Management Systems \| Document Management \| Document Management Software \| FDA \| FDA Compliance \| Pharmaceutical Industry

Implementing Breakthrough Technology for Clinical Development Modeling and Simulation sponsored by Univa UD CASE STUDY: When GlaxoSmithKline was challenged with improving efficiency in modeling and simulation, their clinical development research team turned to Univa technology for faster methods of establishing and running models for a drugâ€™s effects on the body. Posted: 03 Apr 2008 \| Published: 01 Apr 2008 TOPICS: Cluster Computing \| Cluster Management \| Data Centers \| FDA \| FDA Compliance \| Grid Computing

Cloud Compliance Technical Guide sponsored by SearchCloudSecurity.com WHITE PAPER: Check out this expert technical guide for a global perspective on emerging cloud compliance issues. Posted: 02 Apr 2013 \| Published: 31 Dec 2012 TOPICS: Cloud Computing \| Cloud Security \| Compliance (Finance) \| Compliance Audits \| Compliance Best Practices \| Regulations \| Regulatory Compliance \| Security \| Security Management

5 ways to gain end-to-end visibility sponsored by Axway WHITE PAPER: Count down five ways to gain end-to-end visibility into your entire file transfer ecosystem, and learn how you can use this knowledge to eliminate security risks and ease data management, by consulting this resource today. Posted: 16 Apr 2013 \| Published: 31 Dec 2012 TOPICS: Collaboration \| Data Governance \| Data Loss Prevention (DLP) \| Data Management \| Data Security \| File Sharing Protocols \| File Transfer Protocols \| Information Governance \| Information Management \| Information Security \| Regulatory Compliance \| Risk Management \| Security Management

Why Your Security Strategy Needs Universal Log Management sponsored by Hewlett-Packard Company WHITE PAPER: Do you know where your vulnerabilities are? This white paper discusses the log management landscape and the solution that protects modern networks. Posted: 02 Apr 2013 \| Published: 31 May 2012 TOPICS: Cybersecurity \| Log Management \| Malware \| Regulatory Compliance \| Risk Management \| Security \| Security Event Management \| Security Management \| Security Policies \| Security Systems \| Security Threats

Case Study: Novagalicia Secures Critical Applications with HP Fortify sponsored by Hewlett-Packard Limited CASE STUDY: Assessing and improving the security of applications used in financial institutions is paramount. This case study explores the security-as-a-service (SaaS) testing solution one bank used after a merger to quickly and accurately assess their nearly 400 applications. View now to learn more! Posted: 06 May 2013 \| Published: 30 Apr 2013 TOPICS: Application Security \| Applications Management \| Financial Industry Organizations \| Managed Security Services \| Payment Card Industry Data Security Standard Compliance \| Regulatory Compliance \| Risk Assessment \| Risk Management \| Security \| Security Audits \| Security Best Practices \| Security Management \| Security Managers \| Security Policies \| Security Software \| Security Systems \| Security Threats \| Vulnerability Assessments \| Vulnerability Management

American Bankers Association Case Study: Helping member banks achieve their business goals sponsored by Cornerstone OnDemand CASE STUDY: In this case study, learn how the premier financial services membership group American Bankers Association (ABA) was able to empower its workforce, streamline learning and course delivery, cut costs, and more by using a single, integrated cloud platform. Posted: 16 May 2013 \| Published: 31 Dec 2012 TOPICS: Cloud Computing \| Customer Satisfaction \| eLearning \| eLearning Software \| Employee Performance Management (EPM) \| Human Resources Management \| Human Resources Services \| Human Resources Software \| Regulatory Compliance \| Training \| Training and Educational Services \| Training Software \| Workforce Management Software \| Workforce Planning

After Antimalware: Moving Toward Endpoint Antivirus Alternatives sponsored by Webroot EGUIDE: This E-Guide from SearchSecurity.com outlines why - although endpoint antimalware has become ineffective - organizations today cannot live without it. In addition, learn about alternative methods available to protect your network and endpoints. Posted: 06 May 2013 \| Published: 06 May 2013 TOPICS: Access Control \| Endpoint Security \| Malware \| Network Security \| Network Security Software \| Regulatory Compliance \| Security \| Security Management \| Security Managers \| Security Software \| Security Threats \| Virus Detection Software \| Virus Protection

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