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

Berlin, Germany

Course No 16197


Costs

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Speakers

Thomas Brandacher, PWC Consulting

Lasse Janz, Dräger, Germany

Florian Rauch, DHC Dr. Herterich and Consultants

Stefan Staub, DHC Dr. Herterich and Consultants

Stefan Temps, DHC Dr. Herterich and Consultants

Bob McDowall, McDowall Consulting

Yves Samson, Kereon AG

Jürgen Schmitz, GSK

Programme

SAP: Validation and GMP Compliance


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
  • SAP S/4 Hana innovation highlights
  • Transformation scenarios to SAP S/4 HANA
  • Challenges for the validation approach
  • Validation of S/4 HANA as cloud deployment
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)
Audit trail in SAP
  • Compliance for audit trails: definitions and requirements
  • A risk-based approach to audit trails
  • Implementing audit trails
  • Audit trail reviews
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?
GMP compliance for SAP authorisation
  • User and authorisation management
  • Documentation approach for authorisation
  • Testing of authorisation requirements

Virtual IT-Systems in a GxP Environment


Principles of IT qualification and validation
  • 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
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
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
Compliance requirements for virtual systems
  • IT Infrastructure Platform
  • Server Platform Qualification
  • Virtual Platform considerations
  • Maintaining the Qualified State during operation
Overview of the virtualisation platform
  • Platform components
  • Platform operation
  • Handling of SANs and VMs
Qualification of the virtualisation platform
  • Requirements gathering
  • Platform design
  • Qualification planning
  • Supporting processes
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
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
Virtualisation of laboratory equipment / Desktop virtualisation
  • Use cases for virtualisation in a laboratory environment
  • Operating a virtual system
Show and tell: Virtualisation documentation
  • Technical Requirements Specification
  • Configuration Specifications
  • Installation Qualification
Change & Configuration Management
  • Regulatory requirements
  • What is a change?
  • Definitions of change management & configuration management
  • An outline change management process
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
Workshop: Risk-based approach to planning of virtualisation platform
The participants should assess and control the risks related to the virtualisation of some critical systems, such as DMS, CDS, ERP, LIMS, process historian

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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