SAP: Validation and GMP Compliance AND Virtual IT-Systems in a GxP Environment

SAP: Validation and GMP Compliance AND Virtual IT-Systems in a GxP Environment

Copenhagen, Denmark

Course No 15905


This conference already took place.

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SAP: Validation and GMP Compliance
14-17 November 2017, Copenhagen, Denmark

Introduction SAP Validation
  • Legal requirements
  • Process oriented vs. transaction oriented validation
  • Best practice approach
  • Agile vs. V-Model
SAP Configuration Management vs. Validation Approach
  • Implementation Approach
  • Customizing and Developments
  • Change and Transport System
  • Enhancement Packages and Business Functions
System landscape of SAP
What is needed and what needs to be validated (high level risk assessment)
Introducing the SAP modules
Standard risk assessment for each module
Live demo
Using SAP Solution Manager as a Validation platform
  • Project Tool in a regulated environment: Document management, Test management, Document status report
  • Support Tool: Incident management, Integrative change management
Special features of SAP HANA
  • Big Data in the regulated environment
  • Differences between conventional and the in memory database
  • What will be new in S/4 HANA Datamigration from old Systems
  • Validation efforts fort he cloud solution
Pharma process landscape
  • IT systems and pharma processes
  • Special features of pharmaceutical processes
  • Processes, IT systems and GxP compliance
Process harmonisation and standardisation using a template strategy / SAP and GMP Compliance
  • Functional gaps
  • Process driven system functionality
  • Compliance driven system functionality
Managing a global SAP program in a validated environment
  • 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.
Data Migration
  • A strategic approach to data migration
  • Regulatory requirements and data migration
  • Validating the data migration
Data Integrity and SAP
  • Regulatory requirements (FDA, EU, MHRA)
  • Critical processes (QC)
  • Roles and responsibilities
  • SAP support tools (MDG)
Processes and experiences with validation of SAP within a regulatory context
  • Change management; IT Validation and electronic record keeping 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?
Audit trail in SAP
  • Compliance for audit trails: definitions and requirements
  • A risk-based approach to audit trails
  • Implementing audit trails
  • Audit trail reviews
GMP compliance for SAP authorisation
  • User and authorisation management
  • Documentation approach for authorisation
  • Testing of authorisation requirements

Virtual IT-Systems in a GxP Environment
16-17 November 2017, Copenhagen, Denmark

IT Infrastructure in a GxP Environment
  • Regulatory requirements
  • Definitions
  • Validation and qualification
What is Virtualisation?
  • Definitions
  • Physical platform foundation requirements
  • Software for virtualisation
  • Virtual platform options
Benefits of virtualisation
  • On demand infrastructure
  • Speed of implementation
  • Flexibility
Regulations apply to virtualisation
  • Annex 11 key points for consideration
  • IT infrastructure shall be qualified
  • In-house or hosted system
Compliance Requirements for Virtual Systems
  • IT infrastructure platform
  • Server platform qualification
  • Virtual Platform considerations
  • Maintaining the qualified state during operation
Planning of Virtualisation Projects
  • User / Technical Requirements Specification
  • Definition of the installation and deployment approach
  • Definition of backup cycles and scenarios
  • From a virtual server to a virtual farm
  • Efficient planning
  • Qualification planning
Qualification of IT-Infrastructure
  • General Principles of IT Infrastructure Qualification
  • How to do qualification in a real environment vs. what to do in a virtual environment
  • Qualification Activities
  • Roles and responsibilities
  • Installation and Testing
Risk Management
  • ASTM E 2500-07
  • Good Engineering Practice (GEP)
  • Q 9 – Quality risk management
  • GAMP 5, M 3
  • GEP, Qualification, Validation reconciliation
  • NIST-SP 800-30 Risk Management for IT systems
  • HA-Op
Making of a Virtual Data Centre
  • Specification of virtual data centre requirements
  • Do I qualify or validate the hypervisor software?
  • Building and qualifying a virtual data centre
Virtualisation of Laboratory Equipment / Desktop Virtualisation
  • Use cases for virtualisation in a laboratory environment
  • Operating a virtual system
Disaster Recovery Planning
  • Regulatory requirements for disaster recovery
  • Disaster recovery or business continuity planning?
  • Mitigating physical faults
  • Triggers for the plan
  • Testing the plan
  • Keeping the plan up to date
From Virtualisation to Cloud Computing
  • What is cloud computing really?
  • Abstraction of services and IT infrastructure
  • Virtualisation vs. cloud computing
  • Recommendations for a GxP-compliant cloud computing

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