Countdown to implementation of the National Medicaments Control System

//Pharma Level 4/5 Expert

Medical supplies traceability throughout its chain.

R&B Pharma

The traceability solution developed by R&B complies with the legislation in place (Law 11.903/2009 and PL 4069/2015) and is currently integrated with all the major players in serialization hardware and software. Regardless legal provisions, companies in the pharmaceutical segment are increasingly and voluntarily adapting the traceability process for their products as they identify the administrative, commercial and logistics benefits of this system.
According to the World Health Organization estimations, about 19% of drugs consumed in Brazil are counterfeit or smuggled. Traceability is a tool that allows identifying and fighting that kind of crime, which impacts millions of people.

 

Modules

Serialization and aggregation – generation of unique serial numbers to be printed on each drug package as well as the generation of aggregating labels, which streamline the physical transfer of items across the supply chain.

Messaging – communication gateway between the capture of traceability events and its storage within R&B database, also allowing aggregating and disaggregating of items, besides communication with Corporative ERP, regulatory agencies and supply chain partners, all based on each client’s need.

Data Repository and Custody – data storage within R&B database using cloud tool in partnership with Amazon Web Services, enabling the management of all items, in addition to consultations and registrations.

Choose an R&B Pharma sector

R&B is able to support laboratories over whole traceability process, working as consultants and developing projects in conjunction with most of level 1 and level 2 software and hardware vendors. R&B is also able to integrate ERPs as part of the solution for its services’ platform, either for companies located in Brazil or those located abroad, but with production destined for the local market.

R&B Pharma product has native integration with the major shop floor hardware’s on the market.

Check our list of partners and book a technical visit to learn more on the advantages of implementing the R&B system.

Being totally aware of the national market specificities, in special the great volume of picking and packaging process, R&B incorporated to its solutions many tools, which enable greater flexibility and reduced impact on distributors’ operational flow.

R&B Pharma allows greater integration mobility and flexibility, improving the work of operators in daily distribution.

RFID technologies and 1D and 2D bar codes are the means applied for traceability information flow across the supply chain.

R&B enables dispensing points - drugstores, hospitals, clinics and healthcare centers - communicate to Anvisa’s central database, in addition to managing inventories as to minimize losses by expiry date and have the chance to consult the drug authenticity.

In cases of hospitals with in-hospital processes already implemented, R&B Pharma enables easy integration providing drug traceability until its consumption by the patient.

Access Platforms

Desktop – the R&B web-based platform allows users to connect to the system from any internet connection, every interaction is made from a management dashboard, which allows consultations, registrations and perform traceability events

PDA – from a better understanding of its clients’ operational flow, R&B developed a mobile solution to perform traceability events

 

Applied Technologies

RFID Labels – generation of radio frequency labels for cases and pallets

Two-dimensional Codes – generation of Datamatrix codes and QR Code for identifying items and traceability events

One-dimensional Codes – generation of SSCC 128 codes to perform aggregations

 

Features

Pioneering – always up-to-date with Anvisa communication protocols, R&B also participates in many study groups on drug traceability including the group study currently working to develop Anvisa’s central database in conjunction with Gaesi/Hospital das Clínicas/GS1/Libbs

Integration flexibility – Being aware of each client’s needs, R&B Pharma is ready to connect to the major serialization hardware and software solutions on the market

Safety – R&B Pharma has all national and international safety requirements and certificates, such as: FEDRAMP, ISO 27001, OUTH 2.0, SOC3, PCI DSS LEVE 1, among others.

Validated Software – The validation conducted by Five Consultoria certifies that R&B Pharma complies with ANVISA’s validation guide requirements, GAMP 5, FDA 21 part 11 and ANMEX 11 EMA, aiming to: i) ensure information integrity of serialization processes and traceability events; ii) contribute to quality improvement enabling the pharmaceutical industry to indicate the origin of its products; iii) allow the use of automated and integration resources available in the system; iv) allow the verification and validation of logistics processes.

FIVE Consultoria | Validação de Sistemas Computadorizados | Qualificação de Equipamentos e Utilidades

 

R&B Pharma solution positioning – Participation Levels

 

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