In partnership with NUS

Academy of GxP Excellence since 2009



To learn to establish validation programs; acquire understanding of the regulatory requirements and expectations for the validation of computer systems used in pharmaceutical and biological industry; learn and understand the process and methodologies on computer system validation and be able to apply the knowledge and principles to specific systems and cases.




This course is designed to provide an overview of the various aspects of computer systems validation, related validation documents and to provide the basis for compliance and implementation.  The course addresses the rules, tools, and techniques to develop and implement a validation program or a project to validate a specific system.  The course provides the principles for computer validation and offers a framework and the methodologies to conduct validation projects.

The emphasis is on the most recent rules and techniques focusing in the relevant regulations, the system life cycle including requirements, design/build, testing, qualifications and maintenance, 21 CFR Part 11 Electronic Records and Electronic Signatures and the journey this regulation has taken, vendor audit, acquired and developed systems, validation master plan, the validation project, risk assessment and management, SOPs, requirements documentation, change management, and related FDA Guidance documents.


Course Outline


  • Validation Overview

  • Regulations and Regulators

  • GAMP5 (Good Automated

  • Manufacturing Practices)

  • Qualifications, IQ/OQ/PQ

  • Annex 11

  • 21 CFR, 11 Electronic Records and

  • Electronic Signatures

  • Risk Assessment and Management

  • The System Life Cycle and Validation

  • Strategies (Planning Stage through system retirement)

  • Vendor Audit

  • Validation Plan and Project Management

  • Spreadsheet Validation

  • SOPs and Training

  • Case Studies


Learning Outcome


Upon completion of this course the attendees will be able to:

  1. Understand the various regulations and guidelines from regulatory bodies and industrial bodies such as 21 CFR 11, GAMP5, and Annex 11

  2. Understand the elements of a System Life Cycle approach

  3. Understand the different classifications and types of computer systems, from the simple GAMP Class 1 systems to complex, bespoke Class 5 systems; from personal computer-based systems to industrial PLC systems.