This collection of IVT Computer and Software Validation Products will guarantee compliance in the ever-changing and evolving CSV environment. With two ebooks, five conference compendiums, and two conference presentations, this toolkit offers strategies for electronic records and signatures management, the emergence of cloud computing and virtualized environments, international regulations and guidances, risk management and change control integration, automated testing tools, building software, data integrit
Products in this Toolkit
Computer System Design Robert Smith System Design and Control Robert H. SmithThe Nine Most Common Computer Validation Problems: Identify Frequent Deficiencies to Accelerate Your Validation Projects Frank HoustonAccurately Identifying Your Requirements—Will Any Computer System be Right for You? Janis V. Olson
Business Owners, Users or Stakeholders…Who is Accountable for Data Quality, Integrity and Confidentiality?
Download the presentation, "Business Owners, Users or Stakeholders…Who is Accountable for Data Quality, Integrity and Confidentiality?", presented at IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Philadelphia, PA, August 2012.
Download the presentation here.
Deep Dive into Global Regulations–21 CFR Part 11 and Annex 11Implications of Social Media and Increased Usage of Mobile Devices on CSVNetwork Virtualization and Cloud ComputingImplementation of Exploratory TestingIncorporate flexibility into a Risk-Based Approach to CSV Company-WideMeasure the ROI that the CSV function brings to your organizationDownload the 14th Annual Computer and Software Validation AgendaDownload the 14th Annual Computer and Software Validation Compendium
Software Validation: Can an FDA-Regulated Company Use Automated Testing Tools? Janis OlsonConsiderations for Validation of Manufacturing Execution Systems Chris Wubbolt and John PattersonLifecycle Considerations for Device Software John E. LincolnStorm Clouds? Cloud Computing in a Regulated Environment Robert H. SmithBuilding High Quality Software Robert H. SmithComputer System Compliance and Quality Planning Benard T. O'ConnorValidation of Software "In-Product" or "As-Product" John E. LincolnRequirement Management Orlando LopezIntegrating Risk Management into Computer System Validation Timothy...
Sessions include:Qualification of Cloud Infrastructures and Vendor On-Boarding Processes Securing and Validating Excel Spreadsheets Network Infrastructure Qualification Data Migration and Verification Validation of Mobile Devices and Software Applications Development of a Risk-based Impact AssessmentReducing Costs while Maximizing ProductivityIdentifying and Overcoming Data Integrity ChallengesCreation of a Global CSV Gap Analysis Program — Track, Report and RemediateImplementation of a Risk-based Approach to Audit Trailsand much more!Download compendium here