QMS - Computer System Validation applied to Medical Devices and In Vitro Diagnostic Devices

Course Details

Scheduled Events: June 2026
Learning Mode: Online
Language: English
(see more details below)

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Learning Objectives

The course aims to achieve the following objectives:

• Explain the fundamentals of computer system validation, its importance, and its role in quality and regulatory compliance.
• Present the main regulatory references governing validation activities, such as EN ISO 13485, GAMP 5 guidelines, and ISO/TR 80002-2:2017.
• Provide an overview of the Validation Life Cycle (GAMP 5) and guidance on maintaining validation over the system's life cycle.
• Identify common mistakes made during computerized system validation activities.

Who should attend?

Medical device manufacturers, Quality & Regulatory Affairs Managers (QA/RA professionals involved in quality and regulatory compliance), auditors, consultants, IT specialists/system owners, and others will find key tools for drafting validation plans, managing SOUPs, audits, and documentation retention.

Course Agenda

• Introduction to computer system validation
• Definitions, terminology, and key concepts
• Data Integrity and ALCOA principles
• Regulatory framework: application of EN ISO 13485:2016+A11, ISO/TR 80002-2:2017, and GAMP 5 guidelines
• Risk management process phases according to GAMP 5:
  • Initial Risk Assessment and System Impact Determination
  • Identification of functions impacting patient safety, product quality, and data integrity
  • Execution of Functional Risk Assessment and identification of controls
  • Implementation and verification of controls
  • Risk review and control monitoring
• In-depth analysis of the Validation Life Cycle and documentation supporting validation activities:
  • Validation Plan
  • User Requirements Specification
  • Functional/Design Specification
  • IQ/OQ/PQ
  • Risk Assessment
  • Traceability Matrix
  • Validation Report
• System re-validation
• Common errors
• During the course day, practical examples and exercises will be carried out to apply the illustrated principles.
• A Final Exam (optional) is scheduled at the end of the course.

Prerequisites

• Knowledge of EN ISO 13485:2016/A11:2021.
• Participation in the ISO 13485 course is also recommended.

Course Materials

• Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
• Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.

Learning Assessments

• Certificate of competence, in case of successful completion of final exam
• Certificate of attendance, in case of non successful completion of final exam or no exam.

Duration

4 hours.

Scheduled Events

• 23 June 2026, 09:00 am - 01:00 pm (CEST).

Price

490,00 € (per participant, taxation excl.).

Learning Mode

Online, Instructor-Led

Language

Training in English Language