SAP - Validation and GMP Compliance - Live Online Training
18/19 February 2025
Course No. 21605
Speakers
Dr Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Robert Geiger
SAP
Stefan Staub
DHC
Nicole Steffensky
DHC Dr. Herterich & Consultants
Christian Gasper
DHC Dr. Herterich & Consultants
Thomas Pauly
DHC Dr. Herterich & Consultants
Andreas Busse
Carl Zeiss
Károly Földesi
SAP Deutschland
Christina Kiefer
Reusch Rechtsanwaltsgesellschaft
Christian Vogler
Raumedic
Note: All times mentioned are CET.
Objectives
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
What problems could arise during validation and how to solve them
How to maintain the validated state of SAP with the least efforts
Background
SAP S/4HANA has been launched in 2015 as the New Intelligent ERP system. The software is available in both Cloud and Onprem edition. SAP S/4HANA is being called the biggest update to its ERP system in over two decades. Together with the shift to In-Memory database SAP HANA a new user interface (SAP Fiori) was introduced. One of the biggest changes is cloud deployment, parts of SAP Enterprise Architecture are now only available as public cloud software (e.g. SAPs Digital Manufacturing Cloud DM). This has immense implications for deployment in the Life Sciences industry.
The mainstream maintenance for the predecessor products will end in 2027, and SAP has a strong presence in the Life Sciences industry with over 3800 customers. Owing to this timeline 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 Life Sciences customers (for On-prem and Cloud deployments) 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 regulatory requirements like EU GMP Guide Annex 11, GAMP® 5 2nd Edition, 21 CFR Part 11 and FDA CSA draft.
Target Group
This ECA Live Online Training is directed at experienced employees from
IT & IT Service Providers
Quality Assurance / Quality Control
Production / Engineering
who have to deal with SAP S/4HANA in the regulated Environment of the Life Sciences Industry (Pharmaceutical & Medical Devices).
Date & Technical Requirements
Date Live Online Training Tuesday, 18 February 2025, 09.00 h – 18.00 h CET Wednesday, 19 February 2025, 09.00 h – 17.00 h CET
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programme
New Regulations and Guidelines Covering Computer System Compliance in the GMP Area
EMA New Annex 11 Concept Paper
FDA CSA Draft – meaningful or missing the target?
Validation Approach for SAP S/4HANA
Risk-based validation approach for SAP S/4HANA implementation
Risk-based validation approach for transformation SAP ECC to SAP S/4HANA
How to harmonize validation and implementation
Case Study: SAP S/4HANA Conversion @ RAUMEDIC - Challenges in Implementation and GxP Compliance
Transformation from SAP ECC 6.0 to SAP S/4HANA
Various GxP compliance requirements must be met by using an integrated Approach
Added value of the Approach
Challenges and lessens learned from this ongoing project
Qualification of SAP as a Supplier of GxP relevant IT Solutions
General supplier qualification requirements
Possible approaches for the qualification of SAP
SAPs general and GxP-specific offerings to support the supplier qualification
Audit Trail in SAP S/4HANA
Compliance for audit trails: definitions and requirements
A risk-based approach to audit trails
Implementing and testing audit trails
Implementation of SAP S/4HANA and Data Migration
A strategic approach to data migration
Regulatory requirements and data migration
Validating the data migration
SAP Validation and GMP Compliance - Experience from Inspections and Audits
SAP cloud systems in pharmaceutical and medical technology companies
Main investigator focus during inspections of a SAP system
Operation of SAP on cloud hyperscalers (MS Azure/AWS)
Validation and control of SAP updates
Use of SAP test automation Tools
Overview SAP in Life Sciences
SAP Solution Strategy mapped to Life Sciences
SAP Industry Solution Portfolio for Life Sciences
Industry Cloud for Life Sciences Solutions (SAP and SAP Store Partner Solutions)
Business Transformation to enable a composable IT-Platform to support agility and regulations - intertwined implementation and Validation
Key takeaways
Validation of SAP (Public) Cloud Solutions
Challenges in a public cloud deployment model
How can customers gain trust in a public cloud solution?
Validating a cloud solution and staying validated
Case Study: Introduction and Validation of SAP Digital Manufacturing Cloud (SAP DMC) in ZEISS’s Highly Regulated Manufacturing Environment
Manufacturing process template based validation approach
Agile DevOps and roll-out deployment
Keep IT validated – operation of cloud based services
Data Protection and Cyber Security in the Cloud - Legal Challenges and Compliance in Practice
Requirements of the GDPR and the data protection supervisory authorities
Innovative use of health data and the planned European Health Data Space
The EU’s new cybersecurity law: cloud services and the NIS-2 Directive
Practical tips on cloud compliance from a lawyer’s perspective
Trends and innovations in computer-aided systems validation
AI
Digitalisation
Automation
How to Streamline and Speed Up the Validation Process
What are prerequisites to streamline and speed up the validation process?
Steps to streamline the validation process
Efficient, fast methods and tools to speed up the process
The role of the supplier(s)
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
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Testimonials
Seminar Programme as PDF