BrainGate

BrainGate - Secure Pharma Gateway

BrainGate's focus is on manufacturers from the pharmaceutical industry. As middleware, its software provides a user-friendly interface for the reliable exchange of data with the European Hub of the European Medicines Verification System (EMVS). This fulfils the requirements of EU Directive 2011/62/EU on the prevention of counterfeit medicines.

Processes can be viewed and analysed at any time via the web interface. Alerts triggered by the EU Hub can be received by email or transmitted to third-party systems for further processing.

BrainGate simplifies the EU Hub's complex interface and security architecture and provides a user-friendly RESTful API for all EU Hub request types.

The middleware can easily be connected to existing serialisation or track-and-trace systems, enabling data exchange with the EU Hub.

BrainGate can be used seamlessly with Secldent, our system for generating counterfeit-proof serial codes, or connected to your own inventory or third-party systems.

Advantages

In particular, BrainGate offers numerous advantages for pharmaceutical companies and re-importers.

• Reliability: Fail-safe web service with 24/7 availability and 24-hour support
• Efficiency: Automated renewal of EU hub access tokens and encryption and decryption of XML payloads
• Flexibility: A versatile and flexible interface and connection options for straightforward integration into existing systems
• Security: Comprehensive security measures, including an optional validation package and certificate management

Highlights

• Easy connection to the EU hub: BrainGate enables the creation, modification and recall of product master data via the GUI or API, as well as the creation of batches and packages via the API
• Flexible delivery: Responses from the EU hub can be configured to be delivered via email, HTTP queue, HTTP endpoint or Secldent
• Comprehensive evaluation: Detailed monitoring and logging of all requests and responses ensure traceability and compliance

Key functions

Interface:

• Easy use of the RESTful JSON API with bearer token authentication at user level
• Support for all EMVS environments (ITE, IQE, PRD) with separate API endpoints
• Retrieval of process details and logs via the interface
• Flexible delivery options for responses, including email, HTTP queue, HTTP/REST and Secldent

Surface:

• Clear web interface, accessible via desktop or mobile device
• Detailed monitoring and statistics on request types, durations, and responses
• Comprehensive system log and history of all requests and responses (audit trail)
• Ability to create product master data directly via a form, without API or XML knowledge
• Management and configuration of user and customer data, and of API environments and certificates
• Multilingual system interface (German/English)

Supported EMVS EU hub operations:

• Creating and modifying product master data
• Product recall
• Creation and modification of batches and packages
• Recall of batches and packages
• Status query of batches and packs
• Requesting and downloading reports
• Delivery of alerts

Simplified security:

• Automated renewal of EU hub access tokens
• Secure handling and encryption of XML payloads
• A validation package (User Requirement Specification, Functional Specification and Operation Qualification) is available as an optional extra

Would you like to find out more about BrainGate? Then contact us now and arrange a free, no-obligation consultation.