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 27001)
  • Accompanying of technology and product transfers
  • Preparing Product Quality Reviews (PQRs)
  • Conducting of mock audits or preparation and follow-up of audits
  • Preparing & accompanying of authority inspections
  • Deviation management incl. root cause analysis
  • Change processes/change management and CAPAs
  • Conducting gap analyses

Qualification/validation

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

Document management

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

Supplier management

  • Supplier qualification
  • Auditing
  • Preparation of technical agreements

Training

  • Establishing training systems
  • Conducting staff training courses