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Field Services and Consulting in Italy

Many years of experience and ISO 9001 Certification within:

  • Production equipment qualification
  • Ancillary equipment qualification
  • Environment classification and HVAC qualification
  • Thermal qualification of equipment
  • Thermo-hygrometric mapping of storage areas
  • Computer system validation
  • Process instrument field calibration

Our services are completed by ISO 9001 EA37 certified on-site training and GXP and regulatory affairs senior consulting. The training and consulting services offered by our team are characterized by a worktop that is completely customized and tailored to the specific practical needs of the customer.

Our team bases its actions on the continuous search for improvement and customer satisfaction by understanding their needs and expectations and bases its services on the following values:

Professionalism: Determination, competence, search for continuous improvement, the efficiency of services

Ethics: Acting responsibly and transparently, in compliance with regulations and with respect for people

Resourcefulness: Encouraging collaborators to act with creativity and resourcefulness

Teamwork: Teamwork orientation to achieve better results by sharing ideas and skills

Organizational flexibility: Prompt service with short deadlines also thanks to the wide availability of high-quality instrumentation; modular programming for urgent customer needs; high professionalism of the technical staff

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Our Specialties and Regions

Equipment Qualification:

  • Production equipment qualification
  • Ancillary equipment qualification
  • Thermal validation (sterilization, depyrogenation)
  • Equipment thermal mapping (dryers, ovens)
  • Freeze dryers validation
  • Environmental classification HVAC qualification – smoke studies
  • Laminar flow hoods and down cross hoods validation
  • Computer system validation
  • URS preparation
  • Impact assessment
  • Validation Master Plan preparation
  • Design qualification
  • FAT/SAT protocol and witnessing

Process instruments field calibration:

  • Temperature
  • Humidity
  • Pressure/differential pressure
  • pH
  • Conductivity
  • RPM
  • Flowmeters
  • Scales

Training and consulting:

  • GXP compliance
  • Quality Risk Management
  • Sterile production
  • Cleaning Validation
  • Process Validation
  • Product quality review
  • Quality control
  • ICH guidelines
  • Regulatory affairs and dossier preparation

Regions covered:

  • Italy
  • Italian-speaking Switzerland
  • Malta

Meet Team Italy

Gabriele Sardini Gabriele Sardini Director Field Services
Letizia Maccagni Letizia Maccagni GXP and Regulatory Affairs Consultant
Davide Spina Davide Spina Validation Manager
Andrea Ganino Andrea Ganino Sr. Validation Engineer
Andrea Zebri Andrea Zebri Sr. Validation Engineer
Davide Alberghina Davide Alberghina Sr. Validation Engineer
Federico Germinario Federico Germinario Sr. Validation Engineer
Giorgio Viganò Giorgio Viganò Sr. Validation Engineer
Gabriele Pizzighella Gabriele Pizzighella Sr. Validation Engineer
Andrea Gavazzi Andrea Gavazzi Validation Engineer
Andrea Moretti Andrea Moretti Validation Engineer
Francesco Fratini Francesco Fratini Validation Engineer
Luca Boccaletti Luca Boccaletti Validation Engineer
Mattia Grechi Mattia Grechi Validation Engineer
Marta Arrigoni Marta Arrigoni Validation Area Assistant

Get Your Free Consultation Today

Talk to our team today and learn how we can help with your processes and projects.

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