Validated in the Cloud: The regulated route with Computer Software Assurance (CSA)

My 09.10.2024
10:00 am - 11:00 pm

The 2022th GAMP Conference in Mannheim, which took place in November 15, produced a number of encouraging and necessary developments in computer system validation (CSV). In particular, the publication of the 2nd edition of GAMP 5 can be considered a paradigm shift.

Classic computer system validation according to GAMP 5 has been established since 2008 and is considered best practice. However, recent technological developments such as artificial intelligence/machine learning (AI/ML) require Cloud Computing and the Internet of Things (IoT) new solution approaches for CSV. For this reason, ISPE has developed new approaches and integrated them into the GAMP guidelines, which are being adapted by both legislators and authorities such as the FDA, EMA and the ZLG.

Computer Software Assurance (CSA) is a consistent risk-based approach to validating computer systems. It focuses on critical thinking, automation and inclusion Cloud-Providers and suppliers. This enables targeted and highly automated validation of the relevant processes instead of creating extensive documentation without added value.

Through the risk-based approach and critical thinking, the requirements of the computer system or ERP processes are thoroughly evaluated. This allows for more efficient validation by not having to manually validate all functions. Extensive automation, especially with complex computer systems, increases productivity. At Cloudsystems, regular updates are automatically recorded and documented.

We'll show you in this webinar

Innovations and advantages of Computer Software Assurance (CSA).
Supplement to classic computer system validation (CSV).
The most important steps from the process list to risk assessment to test automation
How can KUMAVISION support you?

target audience

The webinar is aimed at all companies in the regulated environment that manufacture medical technology products and/or place them on the market as dealers.

Speakers

Markus Neumann is a consultant at KUMAVISION. His focus is on industry solutions tailored to medical technology with over 350 best practice processes. From his many years of professional experience in the areas of validation, ERP implementation and quality management, he knows both sides of an ERP implementation and incorporates this practical experience into his lectures. > LinkedIn profile

Philip Wilde (Moderation) advises and supports medium-sized companies in digital transformation with a focus on ERP and CRM industry software. The focus is on the medical technology and healthcare market industry. > LinkedIn profile