validAID

  • Requirement Engineering
    • Training of multiple methods for requirement gathering and documentation
    • Conducting interviews with subject matter experts
    • Workshops with representatives from IT and business (Manufacturing/Quality Management/...)
    • Documentation of requirements
  • Conducting Risk Assessment workshops (e.g. FMEA) according to the Quality Management System of the customer
  • Creation / review of all necessary quality documentation for the customer, incl.
    • User Requirement Specification
    • Functional- / Design-Spezification / configuration-Spezification
    • Testates (Functional Tests / User-Acceptance-Tests)
  • Take on Test-Leads responsibilities
    • coordination of test execution,
    • Documentation and tracking of defects
    • Creation of CAPAs / Change Controls for further defect tracking
  • Staff training 


Quality Management (QA)
 | Business Process Analysis (BPMN) | Computer System Validation (CSV)  | Projekt Management (PMO) | Manufacturing Execution Systems (MES)

  

validAID

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Helmut M. Rector
mobile: +49(0)163 246 2978
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