This lecture adresses all aspects of validation that our different groups of students might come accross.
- Responsibles for IT systems in a hospital (data center, PC clients, medical devices as laboratory, X-Ray etc.)
- Operators of computer systems and lab devices
- Manufacturer of medical systems (equipment, software)
The aspects include
- Validation of equipment (focus hospital)
- Validation of network
- Validation of computers (with link to software validation)
- Particular regulations and standards for lab devices
- Regulations and standards: 21CRF part11, short link to ISO9001
- Legal (in terms of security and safety) requirements for (e-) clinical trials
- Trends and comparison of US and EU laws, standards and regulations. Acceptance of each other certifications (EU <=> US, EU countries)
- Who are the responsible authorities?
General guidelines for all lecturers should be considered.