The Swiss Consulting

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Consultancy

GMP Quality System Consultancies

  • Calibration and Calibration Management
  • CAPA -Correctiv and Preventiv Actions
  • cGMP (current Good Manifacturing Practice) Kalite Sistemi
  • Change Control-CC
  • Cleaning Validation
  • Cosmetic-GMP( Cosmetic-Good Manifacturing Practice
  • GMP- Documantations
  • OOS-Out of Specification
  • PQR-Produkt Quality Review
  • Process Validation
  • QRM-Quality Risk Management
  • Qualification
  • RA-Risk Analys
  • SMF-Site Master File
  • SOP-Standard Operating Procedüre
  • URS-User Requirements Specification
  • VMP-Validation Master Plan

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    Consultancy on ISO Quality Systems

  • General Terms for Operating Different Type Examination Entities
  • ISO 13485 – Quality Management Systems for Medical Devices
  • ISO 14001:2005
  • ISO 17020:2005
  • ISO 17025 – General Terms For Qualification of Experimental and Calibration Laboratories
  • ISO 9001:2000, ISO 9001:2008

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    Validation, Qualification and Calibration of Equipment, Rooms, Areas and Systems

  • Clean Room Qualificatinon&Performance Testing, Calibration and Certification
  • Heat and Moisture Mapping
  • Qualification &Performance Testing of Laminar Flow Units
  • Qualification, Calibration and Performance Testing of of Bio-Safety Cabinets
  • Qualification, Performance Testing of HVAC
  • Qualification&Performance Testing of Sterilizers/ Autoclaves/ Hot Air Ovens/ Ovens /Tunnels/ EtO-Sterilizers

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    Auditing

  • 2nd Party Auditing
  • 3rd Party Auditing

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    Solution Partner

  • Establishing and developing liaisons with foreign countries and firms
  • Seeking Solution Partners Abroad

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    GLP Good Laboratory Practices

  • Analytical Method Validation
  • GLP – Good Laboratory Practice
  • HPLC (High-Pressure Liquid Chromatography)
  • Stability Testing Photo Stability testing

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    Medical Devices

  • CE Certification of Medical Devices
  • ISO 13485 – Quality Management Systems for Medical Devices
  • MDD 93/42/EEC – Medical Devices Directive

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