Software Validation

• Introduction to principles of validation, IQ, OQ, PQ, etc.
• Review of regulatory requirements
• Review of GAMP Guidelines
• Risk Analysis
• Categorisation of the computerised system & validation requirements
• Guidelines for determining validation effort with risk assessment
• Approach to new equipment and introduction of new equipment - "Life Cycle Approach".
• Responsibilities within the validation project team.
• FMEA - a tool in validation approach.
• Validation Documentation: SOP, URS, SDS, FDS.
• Computerised Systems Life-cycle Project Phases.
• Categorisation of the computerised system & validation requirements
• Guidelines for determining validation effort with Risk Assessment Case Studies / Examples will be included in order to best communicate the methodology.

Programme overview

Computer system validation is a critical tool to assure quality of computer system performance. CSV enhances the reliability of system, resulting in fewer errors and less risk to process and date integrity.

A primary goal of software validation is to demonstrate that all completed software products comply with all documented software and system requirements.

Confirmation is an important part of the overall design validation to ensure that all aspects of the medical device confirm to user needs and intended uses.

Who is the course for

This course is most suitable for those who wish to gain a good understanding of the principle and processes involved in computerised software validation and regulatory requirements.

Learning outcomes

Learners will have a complete understanding of why Computer Validation is necessary and have a better understanding of the process of providing documented evidence that an electronic system or technology will perform as specified.