Installation

Installation of scales

All products of Bilanciai Porro Srl include installation service by our technical staff or network of qualified dealers throughout Italy.

We believe that product is fully delivered only when: 

  • the product meets our quality standards (factory inspection);
  • the product has the metrology and technical characteristics as required by the customer;
  • the customer is properly trained to understand and manage the functions of the instrument purchased;
  • the product meets performance expectations stated by the customer.

In accordance with the GLP / GMP (1), installation of an instrument of Bilanciai Porro Srl goes through three fundamental stages (IQ, OQ, PQ) which may, at the specific request of the customer, be documented in a logbook issued at the end of the Qualification and containing information on the tests performed, the outcome of the acceptance tests, calibration reports, as well as attestation of successful training of operating personnel.

OQ (Operational Qualification)

The phase of Operational Qualification is the phase in which the instrument is checked from the operational point of view. In general, we can say that this phase of the installation procedure includes:

  • calibration and any adjustment of the metrological characteristics that do not comply with the relevant regulations or the DQ (Design Qualification);
  • marking of terminals according to the applicable regulations;
  • training of operating personnel in the normal use of the instrument and routine maintenance.

At the end of the OQ phase the instrument is metrologically functional and corresponds to the requirements stated.

PQ (Performance Qualification)

Performance Qualification phase concerns only those instruments whose normal operation runs via customized programs made specifically for the customer. In this case we perform a series of additional tests that guarantee the customer that what is required and agreed in the planning phase is actually performed by the instrument. Depending on the complexity of the product, we will proceed to:

  • verify the proper functionality of the application program;
  • perform simulations of the normal operating cycle for which the instrument is used;
  • verify the integrity of data in connection with any processes of interaction with different machines (eg. network connections);
  • check for any bugs or critical situations that can stop the program;
  • check the emergency procedures to be applied in cases of failure.

At the end of the PQ phase the device tool it is suitable for the use for which it was built and properly handles certain operating routines in the DQ phase.


(1) GLP (Good Laboratory Practice), GMP (Good Manufacturer Practice), guidelines that apply specifically to the pharmaceutical industry and which we have adopted with appropriate modifications in different areas to improve the qualification of installation and add value to a crucial service.

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