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  • Consultancy (specific support or long term support)
  • Validation review of specific product development activities
  • Project quality management
  • Project collaboration / realization
  • Project coaching
  • Support for Quality Assurance and Quality Management departments

  • Regulatory compliance / e-compliance, including:
    • Computerized System Validation (CSV)
    • Electronic Records & Signature according to EU Annex 11 and 21 CFR Part 11 (ERES)
  • Definition of e-compliance strategy
    • At project level
    • At corporate level
  • Risk management
  • Definition of system architecture
  • Elaboration and review of various Qualification documents such as:
    • Quality Manual, Quality Directives, Quality Policies (Quality Management System)
    • Validation Master Plans
    • High level SOPs
    • Project respectively system specific Qualification Plan & Report
    • System specific SOPs
    • Specification, e.g. User Requirements Specification (URS), Functional (FS), Design and Test Specifications
  • Global co-ordination of CSV activities (e.g. CH, DE, FR, JN, USA, …) for:
    • GCP, GDP, GLP, GMP departments
  • Elaboration and deployment of global CSV and e-compliance training concepts.


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Last update: 2020-01-25

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