Validating corporate computer systems
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.The white paper "A Pragmatic Approach to Computer Systems Validation" explains the function and benefits of applying a risk-based approach to computer systems validation.The paper defines risk-based computer systems validation as not only a regulatory requirement, but also a practice that makes good business sense.Paper-based computer system validation requires that highly skilled technical resources dedicate approximately 50% of their time on non-value added activities which include the following inefficiencies: Traditional computer system validation requires resources to dedicate a significant amount of effort to create and maintain traceability matrixes during the lifecycle.This creates a compliance risk over time because companies fail to maintain the traceability matrix current during the lifecycle.
Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
This is a big challenge, as oftentimes CSV procedures are not well written, making it difficult to enforce consistency.
The lack of consistency in the process creates the risk of not being capable of complying with the requirements of approved procedures.
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.
Relevant and timely information contained in the white paper includes: Computer system validation is an important component of risk management.