Computer and Software Validation Toolkit

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




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Products in this Toolkit

| Special Edition | Product Code: SPEQ0005 | January 11, 2013 - 7:54 am PST

Computer and Software Validation

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

| Product Code: VIDQ0015 | January 23, 2013 - 12:38 pm PST

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.

| Product Code: VIDQ0012 | January 24, 2013 - 1:35 pm PST

SOPs for Managing Application Service Providers

Download the presentation here.

| Special Edition | Product Code: SPEQ0022 | November 6, 2013 - 2:22 pm PST

Computer and Software Validation Volume II

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...

| Conference Compendium | Product Code: CONF0426 | August 3, 2016 - 8:41 am PDT

2016 Computer and Software Validation

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

| Conference Compendium | Product Code: IVTQ7005 | May 1, 2017 - 2:01 pm PDT

18th Annual Computer & Software Validation - 2017

On April 25-27 in San Diego, CA, computer and software validation experts convened to build robust, compliant,and agile CSV systems. There were 24 plenary and expanded sessions including: Manage changes to GxP computer systems and IT infrastructure Reduce costs in computer and software validation Implement a risk-based approach to electronic data integrity compliance Audit and monitor vendors for CSV compliance Qualification of cloud infrastructures Validation of GxP Spreadsheets Two in-conference workshops: Develop a Roadmap for Implementation of a Global CSV Program and Validation of...

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