Support in establishing and maintaining quality management systems

We take care of your QM system

Monitoring quality systems

  • Establishing, maintaining and further developing of QM systems
    (GMP, 21 CFR, ISO 13485, ISO 9001, ISO 15378, ISO 27001)
  • GAP analyses
  • Deviation management incl. root cause analysis
  • Change processes/change management and CAPAs
  • Preparation of Product Quality Reviews (PQRs)
  • Preparation, execution and follow-up of audits & self-inspections
  • Preparing & accompanying of authority inspections
  • Accompanying of technology and product transfers


  • Validation of processes in the areas of production/cleaning/laboratories
  • Qualification of plants and premises
  • Qualification of laboratory devices
  • Computer validation e.g. enterprise ressource planning systems (ERP) and process control systems

Supplier management

  • Supplier qualification
  • Auditing
  • Preparation of technical agreements

Data integrity (DI) and IT security

  • GAP analyses and risk assessments
  • Identification of critical electronic records
  • Data mapping
  • Establishing of data integrity infrastructures
  • Support in implementing the requirements for IT security according to ISO 27001/ BSI-Standards
  • Conducting training on data integrity and information security issues

Document management

  • Preparing and revising of GMP documents such as Site Master Files, SOPs or manufacturing instructions
  • Introduction of document management systems


  • Establishing training systems
  • Conducting staff training courses