Validating corporate computer systems

Val Genesis VLMS expedites the validation process and removes the inefficiencies that plague paper-based validation processes.

It provides 360 degree visibility for Gx P assets, reduces the audit duration from a few days to just a few hours, improves the efficiency of the entire validation process, enhances consistency and reduces the validation cycle time and cost by some 50%.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

Examples of who will benefit from this webinar include: Compliance and Audit Managers Information Technology Analysts Information Technology Developers and Testers QC/QA Managers and Analysts Clinical Data Managers and Scientists Analytical Chemists Laboratory Managers Automation Analysts Computer System Validation Specialists GMP Training Specialists Business Stakeholders/Subject Matter Experts Business System/Application Testers Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries.

Val Genesis Validation Lifecycle Management System (VLMS) enables 100% paperless and fully automates the CSV process from initial validation to retirement and decommissioning.

Val Genesis VLMS is capable of managing requirements, conducting risk assessments, generating dynamic trace matrices, electronic execution, and enforcing validation requirements through frameworks.

It is good business sense to prove to customers that the existing computer systems do what they are intended to do both functionally and operationally. Computer system validation is required by FDA regulations and international quality standards, including: 21 CFR Part 11, 21 CFR Part 820, ICH Q9, ISO 13416, and European Union’s Annex 11.Val Genesis VLMS is a web-based closed-loop Validation Lifecycle Management System that manages the entire validation lifecycle process, from the Validation Plan, Risk Assessment, Project Planning, Requirements Management, Dynamic Trace Matrix generation and then moving on to test case/protocol development, Electronic Execution and completing the validation life cycle with the Decommission/Retirement process.In addition to the validation lifecycle management process the Val Genesis system supports Change Management, Periodic Review and Cleaning and Usage Log management within the system as closed-loop processes.She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. She is currently active in the PMI, AITP, and Rich Tech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.Traditional computer system validation is an inefficient and time consuming paper based process that is plagued with a significant amount of inefficiencies.

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