SAP Computer System Validation Course Overview

Prerequisites for the SAP Computer System Validation Course

To ensure a successful learning experience in the SAP Computer System Validation course, we recommend that students meet the following minimum prerequisites:

• Basic Understanding of Computer Systems: Familiarity with general computer use and basic software navigation.
• Introduction to SAP: Basic knowledge of SAP systems, including an overview of how SAP solutions are implemented and used.
• Regulatory Framework: Awareness of regulatory requirements, particularly those relevant to pharmaceuticals and biotechnology industries such as FDA 21 CFR Part 11.
• Project Management Basics: Basic understanding of project management principles, as the course covers various project types like fresh implementations, upgrades, and rollouts.
• General IT Knowledge: Understanding of IT terminologies, risk management, and data integrity concepts.

These prerequisites will help you grasp the course content more effectively and ensure you have a foundational grounding in the subjects discussed. We look forward to welcoming you to Koenig Solutions and supporting your learning journey in the SAP Computer System Validation course!

Target Audience for SAP Computer System Validation

1. Koenig Solutions offers an in-depth SAP Computer System Validation course, ideal for professionals involved in regulatory compliance and IT system validation in the pharmaceutical and biotech sectors.

• Validation Engineers

  
  

• Quality Assurance Professionals

  
  

• IT Compliance Managers

  
  

• SAP Implementers and Consultants

  
  

• Regulatory Affairs Specialists

  
  

• System Analysts

  
  

• Project Managers

  
  

• Pharmaceutical and Biotech IT Managers

  
  

• GxP Auditors

  
  

• Data Integrity Specialists

  
  

• System Integration Specialists

  
  

• CSV Documentation Specialists

  
  

Learning Objectives - What you will Learn in this SAP Computer System Validation?

Introduction

The SAP Computer System Validation (CSV) course offered by Koenig Solutions equips students with the knowledge and skills to ensure compliance with regulatory standards and effectively manage validation activities across the SAP system within the pharmaceutical industry.

Learning Objectives and Outcomes

• Understanding Regulatory Compliance Frameworks: Gain a comprehensive understanding of regulatory compliance requirements and the end-to-end scope of validation activities.

• Change Control and Documentation: Learn about change control processes, standard operating procedures (SOPs), and user requirement specifications (URS).

• Risk-Based Validation Approach: Understand and apply risk-based and lifecycle validation approaches to prioritize and manage validation efforts.

• Validation Master Plan (VMP): Learn to develop, implement, and manage a validation master plan with detailed examples and discussion.

• Qualification and Verification: Dive into the types of qualifications such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), including protocol creation and reporting.

• SAP Project Types and System Integration: Explore different SAP project types, such as fresh implementations, upgrades, rollouts, and application maintenance, along with integration of various software systems used in pharmaceuticals.

• **Traceability and Validation Models