Solution, encoding, serialized from medicines according to FMD - Product

 Sant Fruitós de Bages  -  Spain
Verified company
Solution, encoding, serialized from medicines according to FMD
  • Solution, encoding, serialized from medicines according to FMD
Serial Farma the solution to the WDF from beginning to end.The Software SERIAL FARMA managed from the production orders from the ERP business, equipment marking unit, code readers and cameras of vision for the control of marking up the record in the Database, in compliance with the requirements of the FMD and the regulations of 21 CFR 11 part.Much...

Description of the Product

Serial Farma the solution to the WDF from beginning to end.The Software SERIAL FARMA managed from the production orders from the ERP business, equipment marking unit, code readers and cameras of vision for the control of marking up the record in the Database, in compliance with the requirements of the FMD and the regulations of 21 CFR 11 part.Much more than a softwareSERIAL FARMA is a comprehensive solution for adapting your company to the WDF consists of the following stages:• Consultancy and advice in the choice of systems and equipment.• Control and management of the equipment with the software SERIAL FARMA.- Equipment marking.- Teams of reading 2D codes and control of the degree of quality of the print.- Vision equipment OCR/OCV for the validation of the alphanumeric digits “Humanly readable”.- Communications plcs of the line.• Database management for the compliance of the FMDFuncionalidades main SERIAL FARMA:• Management of orders for packaging:Start, end, amounts to manufacture, quantities manufactured, line, etc• Serialization in multiple lines:A single system centralizes the information of serialization and allows gestionarsimultáneamente all lines of packaging of the plant and of the devices demarcaje of each line.• Management and/or generation of serial numbers:The system allows you to receive the serial numbers via xml, or generate the serial number on the basis of information manually entered on the operator display screen.• Encoding in different formats:We have considered 6 different formats: EPC Global, SSCC-64, SSCC-96, SGTIN-64,SGTIN-96, GS1 (for printed Codes), UPC-12 etc.• Aggregation:- The system allows to model and communicate with each one of the markers /- Printers.- Each one of the markers of the line operated by Macsa will identify the tuition of the components and the registration number/identifier of the product a result of the markup.- The system will allow multiple levels of aggregation. Each level of aggregation of their components and subcomponents, and it also sets higher aggregation up to the pallet.• Management of rework:You can report manually or automatically rework through delinterfaz. These data will be taken into account for information to be disaggregated.• User management-21 CFR 11 part:- Screens, maintenance and management of users, groups, permissions, and securities.- Association of permissions for the screens and functionality associated with the diferentesniveles user.- Traceability of the actions performed by the users.- Levels of security for users.- Log logs the actions performed in the system.- Audit trail: log and query changes made to the tables of the database.• Reporting

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