content
Computer system validation (CSV) is a methodical procedure for analyzing and testing computer-based systems in development, production or testing that affect the quality of the product. This is to ensure that they are working as intended and that there is no increased risk. In addition to the FDA in 21 CFR Part 820.70, ISO 13485:2016 now also requires this very explicitly in several chapters.
topic overview
- Overview and reference to ISO 13485:2016 and CFR
- Terminology and overview of GAMP 5 as the most important guide of the CSV
- Course of a validation project from the beginning to the approved process using the V model.
- Explanation and procedure for the individual stages of validation
- Essential contents of an SOP and associated forms for carrying out a CSV
- Practical relevance as an aid to concrete implementation
target group
Employees from development, production, quality assurance and IT.
previous knowledge
Not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
