Axway Biotech Compliance Solutions

Axway solutions provide the governance, security, and community management capabilities Biotech companies and research labs 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, biotech companies 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.

Global eSubmissions

Designed for biotech companies, medical/surgical device manufacturers, and pharmaceutical 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 (EMEA), and the Japanese Ministry of Health, Labor and Welfare (MHLW) have all standardized on Axway eSubmissions for regulatory documentation.

Axway CSOS

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

To improve the safety and integrity of the global supply chain, the United States Food & Drug Administration (FDA), the EU, and Turkey are planning to institute stringent serialization and traceability regulations in the coming months. These regulations will require pharmaceutical supply chain constituents – including biotech companies – to provide drug custodial histories, which trace each drug’s chain of ownership from the pharmacy back to the manufacturer.

Axway Track & Trace is a GS1 standards-based solutions that centrally manage regulatory requirements to reduce the cost and complexity of compliance with pedigree laws.

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, ownership, and event data at any point in the supply chain.

Track & Trace 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.

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