Computerized Systems Validation

“Whoever says, compliance is expensive, should try it without.” – Computerized Systems Validation (CSV) is a topic that continues to stay in the focus as critically important for robust and reliable data generation in scientific research as much as for effective performance of operational activities in biotech R&D and pharmaceutical industry. During the Biotech Atelier 2021 we are coming back to CSV to build up on the sessions held in previous editions with new developments in this area accelerated so rapidly by the immense digital transformation of recent years as a result of changes in global health, economic and technological environment.

This year objective is to present Computerized Systems Validation from different perspectives supporting better understanding of the triggers for development and trends as well as the impact on system compliance and software assurance.

We will provide an overview of new approaches to CSV and current status of their implementation, usage and control, as well as the most efficient ways to handle changes.

Be innovative and at the same time maintain compliance and integrity. It has always been a challenge to get innovation and compliance working together. In the session we shall discuss how the innovative solutions meat the conventional regulatory requirements presenting different strategies and approaches depending on the baseline, resources and objectives.

Solutions recommended or defined by the regulatory guidance will be presented from the industry perspective together with the corresponding developments in real life of pharmaceutical industry where CSV is an integral part of Quality Assurance embedded in all processes and contributing directly to the patient safety and critical product supply.

There will be a panel discussion for participants to raise additional questions and hot topics to the lecturers. It will also be an opportunity to get advices, share or challenge opinions.

The session will conclude with one hour Deep Dive into the best practices providing regulatory details and comprehensive examples of the risk-based approach.

The intended audience of the CSV session is not only among the Subject Matter Experts in Quality, R&D, Production and IT involved in computer validation. The session will also give Managers and Executives a better understanding about the different aspects of current technological development, its impact on regulations and vice versa which is critically important in strategy building, resource allocation and ultimately in making the right business decisions.