Thomas Brandacher, RheinBrücke IT Consulting GmbH, Köln, Germany; formerly Sandoz GmbH, Kundl, Austria
Sven Bajorat, Drägerwerk AG & Co. KGaA, Germany
Andreas Jung, DHC Dr. Herterich and Consultants
Christoph Keppner, DHC Dr. Herterich and Consultants
Stefan Temps, DHC Dr. Herterich and Consultants
You will learn
- How to validate SAP 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
The leading Enterprise Resource Planning (ERP) System in industry is SAP. Meanwhile it has also become the standard solution for pharmaceutical companies.
As the system is used for GMP critical operations (e.g. inventory, master data management, batch release) validation is a must and a critical element of the SAP implementation.
Controlled operations, including Change Control will ensure the validated state is maintained.
This ECA course will offer you shared best practices for the validation of SAP considering recent regulatory requirements like EU GMP Guide Annex 11, GAMP® 5 and 21 CFR Part 11.
This Education Course is directed at experienced employees from IT & IT Service Providers, Quality Assurance / Quality Control, Production / Engineering who have to deal with SAP in a healthcare environment.
All participants get a set of useful templates for download
- Validation plan
- User requirement specifications
- Functional specifications
- Test scripts
- Risk assessment questions
- SOPs for operating the validated system
- Data migration
Introduction SAP Validation
System landscape of SAP
- Legal requirements
- Process oriented vs. transaction oriented validation
- Best practice approach
Pharma process landscape
- What is needed and what needs to be validated (high level risk assessment)
- Introducing the SAP modules
- Standard risk assessment for each module
Process harmonisation and standardisation using a template strategy / SAP and GMP Compliance
- IT systems and pharma processes
- Special features of pharmaceutical processes
- Processes, IT systems and GxP compliance
Managing a global SAP program in a validated environment
- Functional gaps
- Process driven system functionality
- Compliance driven system functionality
- Governance and global framework
- Vendor selection & staffing (including offshoring)
- Ramp up and training
- Documentation approach
- Milestones & key deliverables
- Toll gate reviews
- Data migration approach
- SOX in a project
- Handover to support
- Including templates and selected guidelines
Processes and experiences with validation of SAP within a regulatory context
- A strategic approach to data migration
- Regulatory requirements and data migration
- Validating the data migration
Audit trail in SAP
- Change management; IT Validation and electronic recordkeeping for quality relevant process software as a manufacturer of medical devices
- How to ensure that quality relevant impacts are evaluated when changing a validated SAP system?
- How to ensure that efforts for validation are kept on an efficient level without compromising quality and regulatory requirements?
- How to effectively link system, process and validation documentation?
- How to manage electronic records within SAP?
GMP compliance for SAP authorisation
- Compliance for audit trails: definitions and requirements
- A risk-based approach to audit trails
- Implementing audit trails
- Audit trail reviews
- User and authorisation management
- Documentation approach for authorisation
- Testing of authorisation requirements
GAMP® is a trademark of ISPE - http://www.ispe.org/gamp5