Axway Pharmaceutical Manufacturer Solutions
Axway solutions provide the governance, security, and community management capabilities pharmaceutical manufacturers need to protect against data loss, ensure regulatory compliance, and streamline information exchange processes throughout their business interaction networks.
Policy-based secure email and file attachment management
Axway MailGate provides outbound email encryption, data leak prevention, and complete audit trails for compliance with government regulations, industry standards, and corporate security policies. Using MailGate, pharmaceutical manufacturers can comply with government regulations; define custom lexicons to enforce corporate policies that protect intellectual property, regulatory reports, and clinical trial information; ensure the confidentiality of outbound messages by automatically applying the most appropriate encryption method for recipients; track and document compliance for regulatory and legal risk mitigation; and protect data and systems from spam, viruses, phishing, hackers, and other email threats.
Comprehensive and secure Managed File Transfer (MFT) solutions
Axway MFT solutions offer a broad spectrum of security measures to protect against data loss and improve governance. Complete audit trails simplify and lower the cost of compliance with industry and government regulations such as HIPAA, GLBA, and SOX, as well as with your organization’s internal security and privacy policies. End-to-end monitoring and tracking of file movements delivers granular visibility into your entire file transfer infrastructure — no matter what applications, systems, or platforms you or your trading partners have in place.
Designed for pharmaceutical and medical/surgical manufacturers, research organizations, and biotech companies, Axway eSubmissions integrates seamlessly into existing infrastructures to quickly and efficiently create collaborative connections that improve the efficiency and lower the costs of transmitting reports to both industry partners and regulatory authorities. Regulators around the world, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Ministry of Health, Labor and Welfare (MHLW) have all standardized on Axway eSubmissions for regulatory documentation.
Axway’s Controlled Substance Ordering System (CSOS) makes it easy for buyers and suppliers of regulated pharmaceuticals to reduce operational expenses and increase security while ensuring real-time compliance with U.S. Drug Enforcement Administration (DEA) regulations. CSOS is compliant with CFR21 Part 11 and Drummond-certified to meet FIPS140 requirements, enabling organizations to replace the DEA’s costly paper-based Form 222 with the electronic Form e222. CSOS provides all of the functionality you need to manage an electronic B2B relationship — including certificate management, trading partner/community management, secure communications, encryption, digital signatures, alerting, and tracking.
Axway Track & Trace and Axway ePedigree
To improve the safety and integrity of the global supply chain, the United Stated Food & Drug Administration (FDA), individual U.S. states including California and Florida, the EU, and Turkey are planning to institute stringent pedigree regulations in the coming months. These regulations will require pharmaceutical supply chain constituents to provide drug pedigrees, or custodial histories, which trace each drug’s chain of ownership from the pharmacy back to the manufacturer.
Axway Track & Trace and Axway ePedigree are GS1 standards-based solutions that centrally manage regulatory requirements to reduce the cost and complexity of compliance with pedigree laws.
Axway Track & Trace manages serialized and non-serialized product events in an open framework to allow internal and external trusted parties to access product identification, location, pedigree, and event data at any point in the supply chain.
Fully integrated with Track & Trace, Axway ePedigree guarantees the authenticity of origin and demonstrates possession as pharmaceutical drugs move through the supply chain, delivering a clear trail of ownership at each step of the process.
Axway Solutions for Healthcare Information Security and B2B Exchanges
Public and private healthcare providers and payors around the world face a daunting set of challenges:
• A growing need (and in some cases, a mandate) to create sustainable and secure patient health information exchanges (HIEs).
• Outdated or disjointed IT systems that do not support collaborative data exchange among national healthcare agencies, private insurers, hospitals, doctors, pharmacies, and patients.
• Increasingly stringent government regulations globally – such as HITECH, HIPAA, IHE and PPACA (also known as ACA).
For public healthcare and social protection systems in the EU, and for U.S. healthcare providers and payors, Axway solutions enable organizations to securely integrate and exchange private healthcare, administrative and financial information across disparate platforms.
• Axway business-to-business (B2B) integration solutions automate and integrate supply or value chain activities — such as order processing, delivery, invoicing, payments, and healthcare regulation declarations — that involve multiple organizations.
• Axway managed file transfer solutions enable secure, auditable, and easy-to-manage B2B, Application-to-Application (A2A), and ad-hoc information exchange within existing infrastructures.
• Axway email and identity security solutions safeguard inbound and outbound email traffic, simplify file attachment management, prevent data loss, and ensure compliance with enterprise security rules and government regulations using policy-based security and real-time identity validation.
• Axway enterprise application integration solutions orchestrate end-to-end data exchanges, both within organizations and throughout trading communities of external partners, suppliers, and customers.