Annex 11 in Motion – Implementing Outsourcing of Validation Activities Efficiently and Compliantly

The web session will be held in German. If you only speak English, please contact us by email to arrange a personal online appointment (consulting@dhc-gmbh.com). We look forward to hearing from you!

The new draft of the EU GMP Annex 11 brings fresh momentum to the regulatory requirements for computerized systems – particularly regarding outsourced validation activities.
In the future, companies will need to ensure even more that external partners are qualified, clear responsibilities are established, and compliance is maintained throughout the entire system lifecycle.

At the same time, the new requirements provide an opportunity to make validation processes more efficient and to delegate tasks to specialized partners – without relinquishing regulatory control.

In this webinar, the experienced DGQ auditor and former Head of Quality Computer Systems at Roche, Dr. Wolfgang Schuhmacher, explains what the new Annex 11 draft specifically means for outsourcing validation and IT-related tasks – and what you must pay attention to when outsourcing.

Using the concrete example of the Periodic Review, you will learn which regulatory requirements apply, why this process is often underestimated – and how it can be outsourced safely and efficiently. This way, you can combine regulatory security with operational efficiency.

DATE

Friday, December 5, 2025, 10:00 – 11:00 a.m. => You missed the web session? Then request the podcast now!
No time on these dates? Simply register anyway to secure access to the free podcast!
You will automatically receive it shortly after the web session.

WEB SESSION CONTENT

In this webinar, you will learn:

• What changes the Annex 11 draft brings for the outsourcing of validation activities and what they mean for regulated companies.
• Which responsibilities exist between regulated companies and service providers – what is allowed, what is mandatory, and what can be sensibly outsourced – without losing control or risking compliance.
• How much effort goes into a correct Periodic Review – and how it can be professionally outsourced.
• How DHC Validation as a Service can turn your validation efforts into measurable value, relieving you during the operational phase of computerized systems, reducing risks, and ensuring compliance in the long term.

TARGET AUDIENCE OF THE WEB SESSION

This web session is aimed at IT managers, validation experts and responsible personnel, compliance managers, and SAP consultants who are responsible for the operation and validation of SAP ERP systems in regulated environments.

YOUR BENEFITS

• Over 25 years’ experience in a regulated industry environment
• Over 25 years’ experience in IT compliance and computer system validation
• Extensive expertise in software evaluation and selection
• Interactive exchange with our experienced speaker

PARTICIPATION AND REGISTRATION

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

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

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