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PTWARE | TRACCIABILITA' DEL FARMACO
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PTware è il software per la Tracciabilità del Farmaco. Garantisce, tramite procedure standard, l’importazione di dati necessari per l’elaborazione di flussi XML provenienti da sistemi ERP esistenti o con inserimento manuale.
Tutti i dati vengono opportunamente validati dal software con controlli incrociati. Dopo la validazione il software crea in modo automatico i flussi XML da inviare al Ministero della Salute.
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PTware is the software for Pharma Traceability. It Ensures, through standard procedures, the import of data needed for processing XML streams from existing ERP systems.
All data is properly validated by cross-checking software. After validating the software automatically creates the XML streams to be sent to the Ministry of Health.
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| NORMATIVE REFERENCES |
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The Ministerial Decree 15th July 2004 on the introduction at the “Italian Drug Agency” of a central database designed to track packages of drugs into the distribution system "requires manufacturers, as well as keepers of AIC (Authorization Release Commerce) to gather, record and transmit the data required for the creation of the Data Bank
All persons referred to in art. 5-bis of Legislative Decree 30th December 1992, n. 540, and
subsequent modifications and additions must meet the specifications for collecting, recording and transmission to the central database of information about:
a) Package identification number printed on sticker on barcode type 39;
b) number of the single package found on the sticker in the bar code type 2 / 5;
c) identification number of the sender and the recipient's identification number as part of
being authorized, as shown in the specification attached to this decree.
Manufacturers must also transmit to the central database, the production lot and expiration date for each package of a medicinal product.
Manufacturers, wholesalers and custodians of medical products that provide the health facilities of the National Health Service or private accredited, with the exception of pharmacies open to the public, must also communicate to the central database, the value of supply for therapeutic homogeneous category of medicines and also the number of Defined Daily Doses (DDD) provided.
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PTware allows:
- Data collection shipment from existing ERP systems
- Processing of data collected;
- Assignment identifier “code” to sites internal logistics and customer shipping and billing;
- Control system data collected before;
- Creating XML streams according to the specifications issued by the Ministry;
- Creating Statistical Report XLS
- Managing Waste
- Constantly updated according to the regulations.
PTware software consists of two parallel systems:
- PTS Service: a service for collecting data from existing ERP
- PTS: client interface for monitoring, consultation and sending the information collected to the Ministry of Health
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Anagrafica Clienti Fornitori
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