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, conference compendia, and master plans, 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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| Special Edition | Product Code: SPEQ0005 | January 11, 2013 - 10:54 am EST

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 - 3:38 pm EST

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.

| Special Edition | Product Code: SPEQ0022 | November 6, 2013 - 5:22 pm EST

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: IVTQ7005 | May 1, 2017 - 5:01 pm EDT

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...

GXP | September 26, 2017 - 9:29 am EDT

Data Integrity Strategies for Migrating Data from Legacy Systems

Data migration can be very challenging and can create data integrity issues if not executed with an adequate strategy.One of the biggest challenges is that companies fail to understand the magnitude and impact of migrating data from legacy systems while maintaining data integrity.Prior to the execution of projects that require data migration companies need to understand the risk impact of the legacy data that requires migration.Based on the risk impact of the legacy data companies need to define a data migration strategy that enables compliance with data integrity regulatory requirements.This article...

Conference Compendium | Product Code: IVTQ8045 | April 27, 2018 - 1:39 pm EDT

19th Annual Computer & Software Validation

Downloading our CSV compendia will provide presentations from all of our sessions.Download

Validation Master Plan | Product Code: MVPQ008 | June 1, 2018 - 11:10 am EDT

Master Validation Plan Outlines

Types of Master Validation Plans:Design Project Master Validation Plan: This VMP, which exemplifies the project master plan, is a documented plan containing validation evidence for items utilized during product development, design verification, and design validation activities for a project under Design Controls. In other words, it lists all the validation activities required to test the design requirements during design verification and design validation activities. Design Transfer to Production Master Validation Plan: This is another project VMP. It is used to translate design requirements...

Master Validation Plan | Product Code: MVPQ0009 | August 13, 2018 - 11:58 am EDT

Computer Software Validation Master Plan

In order to make documentation occur quickly, Pleach discussed her EMPTT method. You can reach more about this method in her session review, which appeared in the CSV-themed edition of Journal of GXP Compliance. Also included in her presentation was her examples of validation plan templates, which you can use to streamline your documentation and review processes, and communicate your validation plans with your teams. Download her presentation along with the validation plans today!Download Part 1Download Part 2

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