Introduction to Validation of Software for Regulated Processes
The course focuses on what you should take into consideration when determining the appropriate content
and size of a validation effort applied to software used for regulated processes. In addition, the course provides
guidance on a method of reaching the appropriate depth and rigor of activities through analyzing and evaluating
various aspects of the software and its environment.
Kurset vil desuden være i overensstemmelse med følgende regulatoriske guidelines og regler:
- Den specifikke del af FDA/QSR, 21 CFR 820,70 (i), Automatiserede Processer;
- De generelle begreber for kvalitetssystemer som defineret i QSR (21 CFR 820);
- Den specifikke vejledning af 21 CFR 11 (eSignatur og eRecords); og
- Den generelle FDA software vejledning, General Principles of Software Validation, (GPSV), herunder den specifikke vejledning af kapitel 6, "Validation of Automated Process Equipment and Quality System Software"
..samt standarderne
- EN ISO 13485 (QMS)
- EN 62304 (standalone og embedded software)
- EN ISO 14971 (Risk management)
Course language is English.
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