Content

This lecture adresses all aspects of validation that our different groups of students might come accross.

Interest groups:

  • 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 remarks

General guidelines for all lecturers should be considered.