Computerized System Validation and Software Validation for Medical Device Compliance

Computerized systems and software tools are widely used across the medical device lifecycle, including quality management, design and development, production, complaint handling, post-market surveillance, regulatory documentation and data analysis. When these systems support regulated processes or generate quality-relevant records, manufacturers must ensure that they are suitable for their intended use and operate in a controlled, reliable and traceable manner.

This training provides medical device professionals with a practical understanding of computerized system validation and software validation in regulated environments. It explains when validation is required, how validation activities should be scaled based on risk and intended use and how to document validation evidence in a way that supports audits, inspections and regulatory compliance.

Participants will learn how to define the intended use of a computerized system, assess its impact on product quality and patient safety, plan validation activities, execute testing, manage changes and maintain validated state throughout the system lifecycle.

Key Topics Covered:

• Regulatory expectations for computerized system validation and software validation in medical device environments
• Difference between computerized system validation, software validation, qualification and verification
• Intended use, system boundaries, process impact and risk-based validation scope
• Risk-based validation planning and scalable documentation approaches
• User requirements, functional specifications, configuration specifications and traceability
• Supplier assessment and use of vendor documentation
• Installation qualification, operational qualification, performance qualification and alternative validation approaches
• Validation testing, objective evidence, deviation handling and acceptance criteria
• Validation of spreadsheets, databases, eQMS, ERP, document management systems, labeling systems and other quality-relevant tools
• Change control, periodic review, incident handling, backup, access control and maintaining validated state
• Links to data integrity, electronic records, electronic signatures, cybersecurity and audit trail expectations
• Common gaps and nonconformities identified during audits and inspections
• Case studies, practical examples and Q&A sessions

Benefits

• Understand when computerized system validation and software validation are required
• Learn how to apply a risk-based and intended-use-based validation approach
• Distinguish between validation, verification, qualification and supplier evidence
• Improve the structure and quality of validation documentation
• Understand how to maintain validated state throughout the system lifecycle
• Identify common audit findings related to CSV, software validation, data integrity and change control
• Strengthen compliance of quality-relevant software tools and computerized systems used in medical device organizations

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Quality, regulatory affairs, validation, compliance and audit professionals in the medical device industry.QA specialists, CSV specialists, system owners, process owners and IT professionals. Engineers, developers, production, laboratory and project personnel involved in regulated systems. Suitable for beginners and experienced users of generative AI in regulatory workflows. Basic QMS knowledge is beneficial and no advanced programming skills are required.