Equipment/Machine Software Validation According to 21 CFR Part 11 ,EU Annex 11 & GAMP 5 (Embedded and Computerized Software for pharmaceutical Equipment)

Engineering and Validation

3 days (2 days can be customized)
Course fee

Program Description

Topics to be covered with this training includes:

  • Introduction to Computer System Software Validation
  • Set the Validation Plan (VP) and make Planning for the CSV for Computerizes/Embedded system
  • Category of Hardware and Software
  • Introduction to CSV tests for computerized and embedded system (User authentication, Audit Trail, Backup, Data Recovery, and Disaster Recovery)
  • Issuing the Validation Protocols/Report
  • Regulation and Guidelines

Target Level

  • Validation and Qualification scientists, Supervisor and Manager
  • IT Supervisor or Manager
  • Engineering Department Staff (Maintenance, Project Management, Utilities Engineers)
  • Professionals from service organizations and vendors who serve pharmaceutical clients
  • Quality Department (QA, QC, Regulatory Affairs and Compliance)
  • Regulatory bodies involved in pharmaceutical industries
  • Internal/External Auditors and consultant


Objectives and Expected Results

  • Participants will take Idea the need for Computer Software Validation and especially for the machines used in Pharmaceutical Industries
  • Participants will take idea of how to incorporate equipment CSV withing Computer System Validation Master Plan
  • Participants will take an Idea about the categorization for Software and Hardware According to GAMP5.
  • Participants will take Idea for building the Software Validation Protocols (including Input/Output) for the Computerized (Embedded) Software for Pharmaceutical Equipment
  • Participants will take Idea about different forms used for Computer Software Validation and how to Follow the Risk-Based Approach
  • Participants will take Idea about the regulatory guidelines for the sake of successful inspection

Others Training Materials

Workshop, Sheets and case studies paper will be conducted and implemented during training

Target group

  • -

    Trainer Languages English/Arabic

Sign up

Interested in signing up a group of people for this course?

Please contact our Business Development team:
[email protected]
00962 798756232