In life sciences industries, computerized system validation is a fundamental pillar for ensuring data integrity, regulatory compliance, and control over critical data.
As regulatory requirements continue to evolve, particularly those related to Annex 11, organizations are increasingly encouraged to move away from paper-based approaches in favor of digital, traceable, and secure solutions. The question is no longer whether validation is necessary, but how to perform it efficiently, sustainably, and without unnecessary complexity.
From requirements definition and risk management to testing, documentation, and maintaining the validated state, Computerized System Validation (CSV) is still too often managed through fragmented tools, paper records, or documents that are difficult to maintain over time. This approach generates significant costs, operational burdens, and challenges when managing system changes and continuous improvements.
In this webinar, we will provide a clear, practical, and use-case-driven perspective on how to structure, digitalize, and manage a Specification Verification & Validation (SVV) approach while aligning with current regulatory expectations.
Beyond regulatory compliance, you will discover how paperless validation, integrated into a compliance management software ecosystem, can transform validation into a true driver of operational efficiency and business performance.
We will demonstrate how a dedicated SVV application, integrated within the GxpMax platform, can help organizations:
• Reduce validation costs through the reuse and capitalization of testing data
• Eliminate paper records, improving environmental sustainability and reducing storage costs
• Simplify risk assessments and traceability management
• Automate the generation of validation deliverables
• Facilitate information sharing and collaboration across teams
Join us to discover why digitalizing validation is no longer just a regulatory response, but a strategic opportunity for life sciences organizations.Annex 11 and Paperless Validation
Digital validation: a simple recommendation or a future regulatory requirement?Building a Clear and Controlled SVV Approach
A reminder of CSV principles and the key steps required to implement a risk-based validation strategy.Digitalizing Computerized System Validation
How to structure requirements, risks, testing activities, and validation documentation within a single environment.Integrating Artificial Intelligence into Validation Testing Processes
How AI can support the preparation, execution, and analysis of validation tests while enhancing consistency, traceability, and data reuse.Traceability and Reuse of Validation Data
Leverage existing data, simplify risk assessments, and improve the reliability of validation deliverables.Maintaining the Validated State Over Time
Manage changes, system evolution, and updates efficiently without unnecessary revalidation.Practical Examples and Live Demonstration
Demonstration of the SVV application integrated into GxpMax and a practical illustration of a compliant, paperless, and fully digital validation approach.Do you work in the life sciences industry and are involved in computerized system validation?
This webinar will provide practical insights to help you:- understand expectations related to Annex 11 and paperless validation,
- build a simpler and more efficient CSV approach,
- reduce validation costs and effort,
- improve traceability and compliance,
- transform validation into a sustainable and controlled process.
Free registration
Please fill in the registration form. Confirmation of your registration will be sent to you by email together with information on connexion requirements.
Duration
45 minutes per Webinar. You are able to log onto the Webinar 15 minutes before it starts.
Equipment
Windows or Mac Computer (configuration details will be sent with registration confirmation)
Internet connexion (a high speed connexion is preferable). Microphone and speakers (integrated/USB headset)