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

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FDA 21 CFR 11

FDA 21 CFR 11 Reports

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

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

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

Accenture Technology Vision 2016 sponsored by ComputerWeekly.com ESSENTIAL GUIDE: Leading companies that develop a people first approach will win in today's digital economy, according to the latest global technology trends report from Accenture. Posted: 04 Feb 2016 \| Published: 04 Feb 2016 TOPICS: Business Intelligence \| Business Intelligence Software \| Business Logistics \| Business Management \| Business of Information Technology \| Collaboration \| Data Management \| Data Quality \| Workforce Planning

Benefits of Digital Transformation for Oil and Gas Companies sponsored by TIBCO WHITE PAPER: A recent IDC Analyst Infobrief outlined 6 specific challenges in making sense of oil and gas companies’ data that posed the greatest concern. Access this white paper to view these challenges and to gain exposure to 3 use cases that reveal how analytics can help you outcompete your peers in the oil and gas industries. Posted: 24 Feb 2020 \| Published: 24 Feb 2020 TOPICS: Business Activity Monitoring \| Business Architectures \| Business Intelligence \| Business Management \| Business Metrics \| Business Models \| Business of Information Technology \| Business Process Management \| Business Process Modeling \| Business Processes \| Business Structures \| Business Systems \| Digital Asset Management

Computer Weekly - 5 November 2019: The benefits of API-first software development sponsored by ComputerWeekly.com EZINE: In this week's Computer Weekly, we find out how organisations are using an API-based approach to software development to boost digital initiatives. We examine the potential pitfalls in using cloud storage. And we talk to the Department for Work and Pensions about its four-year project to move from outsourced IT to the cloud. Read the issue now. Posted: 01 Nov 2019 \| Published: 05 Nov 2019 TOPICS: Cloud Computing \| Cloud Storage \| Cloud Storage Services \| Cloud Storage Strategy \| Financial Services \| Outsourcing \| Regulatory Compliance \| Risk Management \| Software Development Methodologies \| Software Development Tools

Computer Weekly - 7 July 2020: The privacy challenges of easing lockdown sponsored by ComputerWeekly.com RESEARCH CONTENT: In this week's Computer Weekly, as pubs in the UK re-open after lockdown, we examine the privacy issues around collecting customer data for contact tracing. We look at how interconnected devices are revolutionising the manufacturing and engineering sectors. And we assess GDPR progress two years after its introduction. Read the issue now. Posted: 06 Jul 2020 \| Published: 07 Jul 2020 TOPICS: Data Analytics \| Data Collection \| Data Management \| Data Security \| Flash Memory \| Internet Appliances \| Internet Infrastructure \| IT Workforce \| Privacy Rights \| Regulations \| Regulatory Compliance

CW500: Key trends for IT leaders in 2017 – technology trends sponsored by ComputerWeekly.com PRESENTATION: A look forward to the 12 months ahead for IT leaders and the key trends of the coming year - this presentation came from Spencer Izard, chief analyst in the enterprise advisory team at Ovum, discussing the major technology trends for this year. Posted: 07 Feb 2017 \| Published: 07 Feb 2017 TOPICS: Business Environment \| Business Intelligence \| Business IT Alignment \| CIOs \| IT Best Practices \| IT Departments \| IT Industry \| IT Infrastructure \| IT Workforce \| Leadership

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

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: 16 Apr 2015 \| Published: 16 Apr 2015 TOPICS: Compliance Best Practices \| Information Governance \| Records Management \| Regulations \| Regulatory Compliance

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