BrainGate – Secure Pharma Gateway

BrainGate — Secure Pharma Gateway

BrainGate focuses on manufacturers in the pharmaceutical industry. As middleware, the software provides an easy-to-use interface for reliable data exchange with the European Hub of the European Medicines Verification System (EMVS). The background to this is the fulfillment of the requirements of EU Directive 2011/62/EU on the prevention of counterfeit medicines.

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

BrainGate abstracts the complex interface and security architecture of the EU Hub and provides an easy-to-use RESTful API for all EU Hub request types.

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

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

Advantages

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

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

Highlights

• Simple connection to the EU hub: BrainGate enables the creation, modification, and recall of product master data (GUI and API) as well as batches and packs (API)
• Flexibility in delivery: responses from the EU Hub can be delivered configurable via email, HTTP queue, HTTP endpoint or SecIdent
• Intelligent authentication: Simple management of certificates and automatic renewal of access tokens as well as secure encryption and decryption of data to the EU Hub
• Comprehensive evaluation: Detailed monitoring and logging of all requests and responses to ensure traceability and compliance

Important functions

Interface:

• Easy to use 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 SecIdent

Interface:

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

Supported EMVS EU hub operations:

• Creation and modification of product master data
• Recall of products
• Creation and modification of batches and packs
• Recall of batches and packs
• Status query of batches and packages
• Requesting and downloading reports
• Delivery of alerts

Simplified security:

• Automated renewal of EU hub access tokens
• Secure handling and encryption of XML payloads
• Validation package (User Requirement Specification, Functional Specification and Operation Qualification) optionally available

Get in touch with us

Use BrainGate to make your communication processes with the European Hub more efficient and secure. Our solution supports you in reliably meeting the requirements of the EU Falsified Medicines Directive and securely managing your product data.

Interested? Contact us to learn more about BrainGate and request a demo.