SAP: Validation and GMP Compliance

SAP: Validation and GMP Compliance

Copenhagen, Denmark

Course No 15901


Costs

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members (does not include ECA membership): EUR 1590,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Thomas Brandacher, PWC Consulting

Lasse Janz, Dräger, Germany

Christoph Keppner, DHC Dr. Herterich and Consultants

Stefan Staub, DHC Dr. Herterich and Consultants

Stefan Temps, DHC Dr. Herterich and Consultants

Objectives

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

Background

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.

Target Group

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.

Templates

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

Programme

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

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