Software Assurance and validation of software for QMS process

Learn the concepts of software assurance and software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software and how to maintain software assurance throughout its lifecycle.

Course description

ISO 13485:2016 introduced requirement #4.1.6 on validation of software used in QMS process. Likewise, the FDA published a guidance on Computer Software Assurance for Production and Quality System Software.

Given the complexity of software design, companies and managers expect hard times when they come to apply classical validation methods to software. Software has its own rules and concepts: failure, bugs, defects and user errors. These concepts and the way to handle them have a significant influence on the validation process. Knowing how to combine requirements on software validation with activities of software development, installation, configuration and maintenance is the key factor to your success in the software medical device industry.

Course outline

• Session 1
  • Introduction
  • Validation process
    • Inventory
    • Selection, specific cases like ERP
    • Effort of validation
    • Additional criteria for validation
• Session 2
  • Design qualification
  • Tailored IQ, OQ, PQ with risk-based approach
  • Special cases: Excel, data backup-restore
  • Maintaining in a validated state

Learning objectives

• Learn the concepts of QMS software validation,
• Learn how to assess risks related to QMS software,
• Learn how to apply IQ, OQ and PQ to QMS software,
• Learn how to maintain software in a validated state.

Who should attend

People working for medical devices or in vitro diagnosis manufacturers:

• Quality Assurance and Regulatory Affairs Managers
• Software Project Managers
• Software Development, Risk Management, and Test Engineers

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