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/validation

  • Qualification of laboratory devices, production equipment and industrial plants
  • Computer validation of process control systems
  • Implementation of measures to ensure compliance with the requirements for data integrity
  • Support in implementing the requirements for IT security according to ISO 27001

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

Training

  • Establishing training systems
  • Conducting staff training courses

Interim management

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