FDA CSA Computer Software Assurance – The Case for Quality

The web session was held in German. If you only speak English, please contact us via email for a personal online appointment (consulting@dhc-gmbh.com). We are looking forward to meeting you!

In the regulated environment, all computer-based systems used must be validated before they are put into productive use. The infrastructure used must be qualified. The maintenance of the valid state must be ensured over the entire life cycle of the system. Until now, GAMP 5 and the associated documentation requirements were considered the benchmark for computer system validation (CSV).

With Computer Software Assurance (CSA), a new paradigm is taking hold. We are eagerly awaiting the FDA’s announced publication on this topic. But already today, we would like to give you an overview of the development so far and point out which challenges and potentials we see.
We will shed light on what has prompted the FDA for the “Case for Quality”, what changes are opening up in terms of effort and scope in the areas of testing and documentation, take a critical look at the often-cited “critical thinking” and outline the potential that is opening up in the context of digital transformation.

Date

Friday, 19 March 2021, 10:00 – 10:45 a.m. => You missed the web session? Then request the podcast now!

Target group of the webinar

This webinar is aimed at specialists and executives from the areas of quality management / assurance and IT at companies in the regulated environment (pharmaceutical & medical technology).

Content of the webinar

• What is Computer Software Assurance
• FDA’s motivation for the “Case for Quality
• Implications / challenges for the future of Computer System Validation (CSV)
• Possible solutions / development potentials of CSV
  Summary and answering of questions

Your benefit

• Overview of CSA and use cases by CSV experts
• Over 20 years of industry know-how in computer system validation
• Over 20 years of consulting know-how in risk management
• Lessons learned from many successful validation projects in the GxP environment
• Interactive exchange with our experienced consultant and other webinar participants

Participation and registration

=> You missed the web session? Then request the podcast now!

The web session was held in German. If you only speak English, please contact us via email for a personal online appointment (consulting@dhc-gmbh.com). We are looking forward to meeting you!

Our web sessions are a free service for customers and interested parties of DHC.
IT service providers and consultants are excluded from participation.