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

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.

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...

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 infrastructureReduce costs in computer and software validationImplement a risk-based approach to electronic data integrity complianceAudit and monitor vendors for CSV complianceQualification of cloud infrastructuresValidation of GxP SpreadsheetsTwo in-conference workshops: Develop a Roadmap for Implementation of a Global CSV Program and Validation of Manufacturing Execution...

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

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...

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