SAP: Validation and GMP Compliance

SAP: Validation and GMP Compliance

Berlin, Germany

Course No 9264


Costs

This conference already took place.

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

Speakers

Thomas Brandacher, RheinBrücke IT Consulting GmbH, Köln, Germany; formerly Sandoz GmbH, Kundl, Austria
Maximiliane Bretz, Dräger
Andreas Jung, DHC Dr. Herterich and Consultants
Christoph Keppner, 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

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

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

Processes and experiences with validation of SAP within a regulatory context
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?

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

Live demo
Audit trail in SAP
Compliance for audit trails: definitions and requirements
A risk based approach to audit trails
Implementing audit trails
Audit trail reviews

GAMP® is a trademark of ISPE - http://www.ispe.org/gamp5

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