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

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FDA 21 CFR 11

FDA 21 CFR 11 Reports

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

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

GDPR: Risk, opportunity and what it means for security professionals sponsored by ComputerWeekly.com RESEARCH CONTENT: This article in our Royal Holloway information security series explains why GDPR is necessary, what it means for security professionals, and how they can approach GDPR in a positive way. Posted: 10 May 2018 \| Published: 10 May 2018 TOPICS: Data Auditing \| Data Classification \| Data Collection \| Data Deduplication \| Data Governance \| Data Management \| Data Security \| Regulations \| Regulatory Compliance

Computer Weekly – 23 July 2019: How Apollo 11 influenced modern computing sponsored by ComputerWeekly.com EZINE: In this week's Computer Weekly, on the 50th anniversary of the Moon landings we look at the influence Apollo 11 had on modern hardware and software. Our latest buyer's guide examines data protection. And we find out how retailers with physical stores are using technology to respond to the rise of online shopping. Read the issue now. Posted: 19 Jul 2019 \| Published: 23 Jul 2019 TOPICS: CIOs \| Compliance Best Practices \| Data Governance \| Data Management \| Data Security \| Data Storage \| Education Industry \| Educational Software \| Enterprise Systems \| Laws \| Privacy Rights \| Retail Trade Industry \| Service Level 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

CW ASEAN: European data law - be aware and prepare sponsored by ComputerWeekly.com EZINE: Businesses across ASEAN will soon have to comply with a new data protection law – the General Data Protection Regulation (GDPR) that will apply to companies that collect the personal data of Europeans. In this month's edition of CW ASEAN, we look at how ASEAN is gearing up for the GDPR, the current state of compliance and its impact on businesses. Posted: 08 Feb 2018 \| Published: 08 Feb 2018 TOPICS: Cybersecurity \| Data Analytics \| Data Collection \| Data Management \| Data Security \| Information Governance \| Information Management \| Laws \| Storage Security

IDC Flash: IBM Releases IAM for Mobile, Cloud and Enterprise sponsored by IBM WHITE PAPER: Gain insights into IBM's threat-aware IAM solutions focused on enabling identity as the new security perimeter. Posted: 09 Oct 2014 \| Published: 29 Nov 2013 TOPICS: Access Control \| Access Control Software \| Authentication \| Cloud Security \| Compliance Audits \| Compliance Best Practices \| Compliance Software \| Identification Systems \| Identity Management \| Identity Management Software \| IT Best Practices \| IT Departments \| IT Governance \| IT Industry \| IT Infrastructure \| IT Management \| IT Managers \| Mobile Device Management \| Mobile Workers \| Regulatory Compliance \| Risk Management \| Securities Industry \| Security \| Security Audits \| Security Best Practices \| Security Industry \| Security Infrastructure \| Security Management \| Security Managers \| Security Policies \| Security Software \| Security Systems \| Security Threats \| SSO \| Vulnerability Management

Protect People, Processes and Technology from Web Application Threats sponsored by IBM WHITE PAPER: Securing externally facing applications is an important step toward safeguarding your critical assets. Find out why. Posted: 08 Oct 2014 \| Published: 29 Nov 2013 TOPICS: Compliance Best Practices \| Cross-Site Scripting \| Cybersecurity \| Data Security \| Hackers \| Internet Security \| Payment Card Industry Data Security Standard \| Regulatory Compliance \| Risk Assessment \| Risk Management \| Security \| Security Best Practices \| Security Industry \| Security Management \| Security Managers \| Security Threats \| Virus Protection \| Vulnerability Assessments \| Vulnerability Management \| Web Application Security \| Web Applications Management

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

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