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

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FDA 21 CFR 11

FDA 21 CFR 11 Reports

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

Beyond Nine to Five sponsored by ComputerWeekly.com BOOK: In this extract from his book, Ade McCormack offers guidance to enable you to move forward in your career with the minimum of anxiety as digital technology fundamentally changes the nature of work. Posted: 17 Aug 2015 \| Published: 17 Aug 2015 TOPICS: Business of Information Technology \| Business Processes \| Careers \| Productivity

Memorandum of points and authorities by David Godkin (with highlights) - 20 May 2018 sponsored by ComputerWeekly.com RESOURCE: David Godkin, counsel for app developer Six4Three, outlines the legal arguments that will be used in the case against Facebook, as well as the relevant cases, statutes and authorities that apply. Posted: 06 Nov 2019 \| Published: 06 Nov 2019 TOPICS: Application Development \| Application Programming Interfaces \| Data Collection \| Data Profiling \| Laws \| Privacy Rights \| Social Networking

Top 10 startup stories of 2019 sponsored by ComputerWeekly.com EGUIDE: A persistent theme in this year's Computer Weekly startup coverage was collaboration, but this time with a particular emphasis on building ecosystems. Across Europe, startups have been pushing to build collaborative ecosystems in both the public and private sector alongside their partners. Here are Computer Weekly's top 10 startup stories of 2019. Posted: 23 Dec 2019 \| Published: 23 Dec 2019 TOPICS: Artificial Intelligence \| Business Development \| Business Environment \| Business Intelligence \| Business Management \| Collaboration \| Data Management \| Project Management

The Maturity Model for Governance, Risk, and Compliance sponsored by Aptible EBOOK: For more than a decade, the GRC framework has helped companies maintain their data integrity and manage risk in an increasingly digital world. But with compliance growing more and more complex, your GRC operations need to mature as your business does. Scrutinize this guide to understand how to evolve your GRC model in 4 levels. Posted: 07 Dec 2020 \| Published: 07 Dec 2020 TOPICS: Compliance (Systems Operations) \| Compliance Audits \| Compliance Best Practices \| Compliance reporting software \| Compliance Software \| Governance, Risk, Compliance (GRC) \| Regulatory Compliance \| Risk Assessment \| Risk Management

The gender pay gap sponsored by ComputerWeekly.com RESEARCH CONTENT: This survey of 1,000 UK workers by CV-Library found that the pay gap is still a concern for professionals working in the UK. Posted: 26 Apr 2017 \| Published: 26 Apr 2017 TOPICS: Business Environment \| Business Management \| Workforce Planning

Records Management Strategies to Maintain Regulatory Compliance sponsored by SearchCompliance.com EBOOK: Data governance needs and mandates make compliant records management difficult in the digital age. In this handbook, learn records and information management strategies to avoid regulatory complications, including mobile device management strategies and how retention/deletion schedules can help – and sometimes hurt – compliant records management. Posted: 04 Apr 2017 \| Published: 04 Apr 2017 TOPICS: Compliance Best Practices \| Information Governance \| Records Management \| Regulations \| Regulatory Compliance

Data Monetization Strategies: Make and Save Money With Data and Analytics sponsored by Information Builders WHITE PAPER: Are you sitting on your data with no plan? Do you know how to capitalize on information you already have? This whitepaper dives into the world of profiting from data. Access now to discover 4 essential steps to getting started, as well as challenges to overcome and a discussion on the importance of data integrity. Posted: 26 Oct 2015 \| Published: 26 Oct 2015 TOPICS: Analytic Applications Software \| Business Intelligence \| Business Intelligence Software \| Business Models \| Business of Information Technology \| Data Management

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