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: Yukon Medical + Propel sponsored by PropelPLM CASE STUDY: In this case study, uncover how a product lifecycle management (PLM) and improved quality management system (QMS) from Propel helped Yukon Medical manage their training process and scale to fit their current—and future—business goals. Download now to discover how Yukon Medical succeeded by switching their legacy systems to Propel. Posted: 13 Feb 2019 \| Published: 31 Dec 2018 TOPICS: Cloud Computing \| Cloud Management \| Compliance Best Practices \| FDA \| FDA Compliance \| Health Care Industry \| Medical Devices \| Medical Software \| Quality Control \| Regulations \| Regulatory Compliance \| Sales Force Automation

5 Minutes with Propel: Integrated Customer Complaint Process sponsored by PropelPLM VIDEO: No company likes getting customer complaints, but in the medical devices industry, companies need to ensure they have an effective and auditable way for managing complaints. Download this video to uncover a modern way for handling customer complaints by integrating CRM, PLM, and QMS. Posted: 18 Feb 2019 \| Premiered: 30 Jun 2018 TOPICS: Cloud Computing \| Cloud CRM \| CRM \| CRM Services \| CRM Software \| Customer Satisfaction \| FDA Compliance \| Health Care Applications Software \| Health Care Industry \| Medical Devices \| Medical Software \| PLM \| PLM 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

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

Computer Weekly – 9 January 2018: Countdown to GDPR sponsored by ComputerWeekly.com EZINE: In this week's Computer Weekly, with the EU General Data Protection Regulation (GDPR) coming in to force this year, we look at the challenges for businesses to comply by the 25 May deadline. We examine the future for HPE as CEO Meg Whitman steps down. And we find out how hyper-converged systems affect your backup strategy. Read the issue now. Posted: 08 Jan 2018 \| Published: 08 Jan 2018 TOPICS: Backups \| Compliance Best Practices \| Data Classification \| Data Collection \| Data Destruction \| Data Governance \| Data Management \| Laws \| Private Cloud \| Private cloud computing \| Security

Use Technology to Drive Diversity: How Compliance Training Software is Helping HR Teams Transform Compliance Training sponsored by Cornerstone OnDemand WHITE PAPER: In this white paper, find out how learning management software can help HR teams transform compliance training into a powerful tool for engaging employees. Explore real world examples, and discover how compliance training software can help organizations minimize risk, streamline regulatory and compliance reporting, and more. Posted: 07 Jan 2019 \| Published: 07 Jan 2019 TOPICS: Compliance Software \| Human Resources Management \| Human Resources Services \| Human Resources Software \| Regulatory Compliance

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 – 3 July 2018: Future-proofing Gatwick Airport's technology sponsored by ComputerWeekly.com EZINE: In this week's Computer Weekly, we go behind the scenes at London Gatwick Airport and talk to its CIO about a critical network upgrade to support passenger growth. Our latest buyer's guide examines automation and intelligent systems management. And we assess the latest technologies for boosting storage performance. Read the issue now. Posted: 29 Jun 2018 \| Published: 29 Jun 2018 TOPICS: Artificial Intelligence \| Database Management \| Network Architectures \| Network Best Practices \| Network Management \| Regulatory Compliance \| Systems Management \| Travel Industry

Computer Weekly – 25 August 2015: Coping with a crisis sponsored by ComputerWeekly.com EZINE: In this week's Computer Weekly, IT leaders discuss their experiences of dealing with disaster and the importance of planning to ensure business continuity. Jaeger's CIO talks about bring the iconic fashion brand into the digital age. And we look at the issues around writing supplier contracts for agile software development. Read the issue now. Posted: 21 Aug 2015 \| Published: 21 Aug 2015 TOPICS: Agile Manufacturing \| Business Continuity Planning \| CIOs \| Disaster Recovery \| Enterprise \| Regulatory Compliance \| Retail Channels \| Software Development Tools

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