Seminar Computerized Systems Validation (CSV)
How to validate your computerized systems audit-proof and without unnecessary efforts
In this seminar, you will learn how to validate your computerized systems (e.g., ERP, compilers, or self-developed EOL testers) in a risk-based, fast, and regulatory-compliant manner and how to create the necessary documents so that you can face future audits without worries.
Get a compact overview of the requirements for the CSV process
You will first learn about the regulatory requirements of ISO 13485:2016 and 21 CFR part 820 for validating computerized systems. We will then illustrate the implementation of proposals from various guidance documents to meet these requirements using a sample ISO/TR 80002-2-based CSV process, which you can adopt directly into your quality system after the seminar.
Learn to limit your validation efforts to the right level right from the start
After the seminar, you will know exactly
- which systems are subject to validation, and when re-validation is necessary,
- how the interaction with IQ, OQ, and PQ works,
- how a risk-based approach can limit the effort required,
- which contents and elements a validation plan contains,
- which methods can be used for testing and validation, and
- how lean documentation of the validation results can be achieved.
Transfer your learnings directly into practice - through concrete examples and valuable tips
Our expert will show you how to apply CSV during the seminar using concrete validation documents from projects that have already been implemented. You will also benefit from valuable tips and learn which typical problems occur during audits and how to avoid them.
You can find the exact learning content as well as the schedule of the seminar in the agenda:
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