SAP – Validation and GMP Compliance
Elke Brodbeck, DHC AG
Dr Thilo Jania, OLYMPUS EUROPA
Christian Kunath, Santhera Pharmaceuticals
Stefan Temps, DHC AG
IT Infrastructure - Qualification and Operation in a GMP Environment
Frank Behnisch, CSL Behring
Dr Bob McDowall, R.D.McDowall
Yves Samson, Kereon
SAP: Validation and GMP Compliance
You will learn
- How to validate SAP S/4HANA in a GMP environment
- Which specific requirements should be taken into consideration in the CSV process
- How to use SAP Solution Manager 7.2 as a validation platform
- What problems could arise during validation and how to solve them
- How to maintain the validated state of SAP with the least efforts
IT Infrastructure - Qualification and Operation in a GMP Environment
- Get an overview of technologies discussed currently in the pharmaceutical environment
- Learn what requirements are placed on the IT infrastructure and its qualification within the scope of GMP regulations
- Principles outlined can be applied to Operation Technology (OT) for production systems
- IT security and cybersecurity has now taken on a central role; here you will learn about the importance of the IT infrastructure in terms of an appropriate IT security concept
- Case studies show you qualification approaches for key IT infrastructure components
- Virtualization is a part of the IT infrastructure; learn strategies for qualifying the virtual machine and the virtualization platform
SAP: Validation and GMP Compliance
SAP S/4HANA has been launched in 2015 as the new intelligent ERP system. The software is available as cloud edition and as on-prem edition. SAP S/4HANA is being called the biggest update to its ERP system in over two decades. Together with the move to in-memory database SAP HANA a new user interface (SAP Fiori) was introduced.
The mainstream maintenance for the predecessor products will end in 2025. Due to this time line a lot of SAP customers have already started the transformation journey to SAP S/4HANA or at minimum have initiated a pre-project.
How will all these technical and functional changes in the surrounding of SAP S/4HANA (user interface, in-memory database, different deployment types) impact the validation approach and the validation scope?
This ECA Live Online Training will provide comprehensive knowledge about how to validate SAP S/4HANA for new SAP customers as well as for installed base customers who are planning a system conversion.
Expect two days full of shared best practices for the validation of SAP S/4HANA considering recent regulatory requirements like EU GMP Guide Annex 11, GAMP 5 and 21 CFR Part 11.
IT Infrastructure - Qualification and Operation in a GMP Environment
In today’s pharmaceutical environment, the IT infrastructure is the backbone for the application of a wide range of software solutions. The requirements for IT security are becoming increasingly important. Only a robust IT infrastructure with suitable network topologies and security concepts can guarantee the appropriate security here.
Pharmaceutical regulations contain few or only indirect requirements for the IT infrastructure. The principles of the EU GMP guidelines state “The application should be validated, the IT infrastructure should be qualified”. Here the phrase “should” corresponds to a “must”! Further information can be found in the revised version of the GAMP® Good Practice Guide “IT Infrastructure Control and Compliance” published in August 2017.
SAP: Validation and GMP Compliance
This ECA Live Online Training is directed at experienced employees from
- IT & IT Service Providers
- Quality Assurance / Quality Control
- Production / Engineering
IT Infrastructure - Qualification and Operation in a GMP Environment
The Live Online Training is aimed at managers from the pharmaceutical industry, suppliers and service companies who plan, qualify and operate IT infrastructure in a GxP Environment.
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At
https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.