Intelligent Traceability Solutions

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Regulatory Compliance Software

Meet Global Pharmaceutical Compliance Requirements with rfxcel Compliance Management Application

In the Pharmaceutical industry countries around the world have enacted laws to enhance patient safety and combat counterfeit drugs from entering the supply chain. These laws are specific to each country and vary widely. The US Food and Drug Administration, European Public Health Commission and other global regulatory organizations are leading many countries with their implementations. The United States, European Union, India, Brazil, South Korea, Saudi Arabia, and other countries have their own unique requirements that have to be met to do business in these geographies.

Compliance is a significant issue for global pharmaceutical manufacturers, distributors, and retailers; due to the complicated nature of the pharmaceutical supply chain and widely varying global regulatory requirements that are becoming increasingly more stringent over time. Compliance with global mandates requires a significant investment to change processes, create functionality, and put systems in place that keep up with the roadmap of each country. Current enterprise systems may be costly and are not flexible to modify. Just creating the requirement specification could take many months; especially in an environment where IT resources are often scarce. Installing a compliance system that can keep up with country-specific requirements worldwide is imperative.

rfxcel Regulatory Compliance Software  provide the industry’s most comprehensive and flexible application with out-of-the-box functionality to fully comply with current and future legislative requirements for global compliance. The application supports standard interfaces for automated system-to-system integrations, as well as an intuitive, easy-to-use web portal for manual operations and queries. rfxcel Regulatory Compliance Software is a completely automated application that supports lot level as well as unit and aggregated serialization. Our solution is recognized as the most feature-rich solution that is easy to implement, integrate, manage and use. rfxcel Regulatory Compliance Software can simplify your country-specific compliance needs. Examples of these needs include support for the US Drug Supply Chain Security Act (DSCSA), the EU’s European Falsified Medicine Directive (FMD), China’s serialization mandates (CFDA), India’s Drug Authentication and Verification Application (DAVA), and many more.

rfxcel Regulatory Compliance Software Benefit and Features: Flexible Compliance Reporting:
  • When to Report – Configurable options that instruct when to trigger compliance report generation (e.g. Ship / Commission / Aggregation)
  • What to Report – Provides multiple global standard file formats which can be selected by Compliance Management users
  • How to Report – Customers can request specific reporting configurations with the flexibility to add or modify in order to meet the unique needs of key trading partners
Standards-Based Approach:
  • Why This is Important – rfxcel Regulatory Compliance Software is developed in accordance with industry standards. Many vendors will claim this but will introduce their own proprietary extensions which make for a more difficult integration with all trading partners.
  • GS1 Standards – GS1 is a global standards organization with a mission for “Transforming how you share information”. Most countries involved in serialization and compliance efforts have adopted GS1 EPCIS (Electronic Product Code Information Services) standards for communications. rfxcel supports EPCIS version 1.0, 1.1 and the latest 1.2 standards. Our EPCIS 1.2 support is backed up by an independent audit of our results which has been commissioned in advance of the formal GS1 certification.
  • Data Formats – Regulatory Compliance Software supports a wide range of data formats: SAP iDoc, PML, EDI, CSV, XML, JSON, GS1 EPCIS.
  • Integration Protocols – rfxcel Regulatory Compliance Software supports all standard integration protocols: SOAP/REST Web Services, AS2, TCP, SFTP/FTPS/FTP, VAN’s
Auditable Data Repository:
  • Transaction Audits – rfxcel Regulatory Compliance Software captures and stores all serialization data sent from the site level systems. Full transaction history of all serialized items and events are maintained. This includes not only receipt of data but any voiding or reprocessing of events.
  • Master Data Audits – Any change to master data is fully audited with before and after information, as well as time and user ID.
About rfxcel Solutions
rfxcel is committed to supporting industry standards. Our software is designed according to the internationally accepted ANSI/ISA S95 standard. This enables an efficient solution that integrates with external packaging equipment, line controllers, and central repositories via standard interfaces for seamless communication. This architecture ensures seamless information exchange with all partners in the supply chain.

From its early beginning, rfxcel’s Supply Chain & Traceability Software was developed with a core design principle for information flow; “No Garbage In means No Garbage Out”. rfxcel continuously monitors incoming data to ensure data quality. This focus on the quality of the data entering into our solution minimizes issues when reporting to downstream partners and agencies.

Our software is deployed to customers via a private cloud that is dedicated to that individual customer. This provides our customers with full control of their environment. Customer software instances are not automatically updated without a customer’s approval. There is no forced upgrade. The customer can determine what upgrades to accept, and when these upgrades should be applied. rfxcel's private cloud approach allows customers to validate and test their upgrades in accordance with the customer’s quality standards.

rfxcel is here to provide the industry the solution that best fits their needs and requirements. For more information and a 30-minute demo please contact us.