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Service Area
  • mailogo  Mail: support@bottazzi.it
  • telelogo  Tel: 0444 964141
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This service is offered to companies who work in regulated environment, where tools must conform to the most recent FDA (Food and Drug Administration) and USP standards for the pharmacopoeia. The FDA requires that regulated companies must follow Standard Operating Procedures (SOP) regarding the operation of the instrumentation, calibration and maintenance, backup and archiving software. Partners have developed specialized protocols for qualification and validation tools specific to the customer. Knowing the way that the instruments were designed, how they work and their performance, we can provide validation and qualification of the instrumentation.

Product qualification

The service includes a qualification of the installation of the instrument, which ensures performance over time. The service is delivered to the customer in order to obtain and maintain regulatory compliance required by the FDA.
  • IQ- Installation Qualification: certification of the instrument with use of validated procedures and standards
  • OQ- Operational Qualification: certification of the instrument with use of validated procedures and standards certificates, and an "empty" test run (certify that the instrument will "work" as expected).
  • PQ- PPerformance Qualification: certification of the instrument with use of validated procedures and standards certificates, and proof of working with the product (it is certified that the instrument is able to "work" with the product).
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