Commissioning,Start-up &Troubleshooting

We have highly qualified personnel able to carry out:

— Construction checklist
— Assessment of systems, audit activities and assistance for FAT and SAT
— Mechanical completion and punch list management
— Assistance in the preparation of commissioning packages
— Commissioning and commissioning assistance
— Start-up of HVAC systems and clean utilities
— Balancing and “troubleshooting” of new or existing HVAC systems, black & clean utilities


Validation activity

For equipment, HVAC, utilities and process equipment, computerized systems.

Drafting of

— Quality risk management
— GMP reviews
— Validation Master Plan (VMP)
— Risk Assassment (RA)
— Standards of Operating Procedures (SOP)
— Verification of vendor documentation compliance with GAMP guides.

Instrumentation calibration and metrology

Drafting and execution of protocols:

— Design Qualification (DQ)
— Installation Qualification (IQ)
— Operational Qualification (OQ)
— Performance Qualification (PQ)

Integrated services

We propose integrated services for routine calibrations and qualifications and we are able to manage the plants, instruments and equipment present throughout the plant in total autonomy:
— Production
— QC and QA laboratories
— Stores

A service that covers from the planning and coordination phase to the execution of field tests and archiving of reports, guaranteeing specialized assistance even in the event of failure. We deal with calibration management, a service by which we take care of our client’s tools set, through the management of their ordinary and extraordinary maintenance and certification at accredited centres:
— Sending the certificate
— Certificate management
— Guarantee of service even in case of non-compliance