Team Italy
We are a young and dynamic team that supports companies in the pharmaceutical, medical devices, food and cosmetic sectors in the processes of validation and qualification of production and ancillary equipment, which are joined by important seniorities for training and consultancy in the GXP field.
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
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
- Control system periodic review
- IT infrastructure validation
- ERP systems validation
- Excel sheet validation
- Software selection and development
- Lab data management and digital tools
- EHS impact evaluations
- EHS and business continuity plans
- Sterility assurance engineering
- Sterility assurance expertise and bio-decontamination services
Regions covered:
- Italy
- Italian-speaking Switzerland
- Malta
Get Your Free Consultation Today
Talk to our team today and learn how we can help with your processes and projects.