Services for plant engineers and manufacturers of laboratory equipment in the fields of pharmaceutical and medical technology

When QM standards and GxP requirements need to be met


  • Qualification of laboratory devices, production equipment and industrial plants
  • Computer validation of process control systems

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

Monitoring QM systems

  • Establishing, maintaining and further developing of QM systems
  • Preparing and revising of SOPs and instructions
  • Introduction of document management systems

Supplier management

  • Supplier qualification
  • Auditing
  • Preparation of technical agreements


  • Establishing training systems
  • Conducting staff training courses

Interim management

  • Quality management
  • Information security management
  • Production
  • Business development
  • Marketing & sales