Bayer is a global enterprise with core competencies in healthcare and agriculture. Their commitment to innovation and sustainability drives them to develop cutting-edge solutions that address some of the world’s most pressing challenges.
As a leader in the life sciences industry, Bayer prioritizes transparency, security, and compliance to maintain trust with stakeholders and meet evolving regulatory requirements.
Challenge
As the regulatory landscape for medical device cybersecurity evolved, Bayer recognized the critical role of Software Bill of Materials (SBOMs) in maintaining security, compliance, and transparency. With increasing scrutiny from the FDA and global regulators, Bayer took proactive measures to enhance its SBOM management processes.
To remain ahead of regulatory changes and meet customer expectations, Bayer sought a solution that would:
- Ensure compliance with FDA guidelines, NTIA minimum standards, and international regulations by maintaining accurate, complete, and transparent SBOMs across global markets.
- Gain a comprehensive understanding of software components, including open source, commercial off-the-shelf (COTS), and proprietary software.
- Automate workflows to efficiently track and manage the growing volume of software vulnerabilities.
- Reinforce its standing as a technology leader by delivering secure, transparent products that build trust with key stakeholders.
By adopting a strategic approach to SBOM management, Bayer focused on leveraging cutting-edge tools to simplify complexity, reduce manual effort, and achieve seamless compliance throughout the product lifecycle.
Solution
- Comprehensive SBOM Oversight: Unified data integration from both development and runtime environments to generate complete and actionable SBOMs.
- Automated, Scalable Processes: Optimized workflows that minimize manual intervention, accelerating regulatory submissions.
- Regulatory-Ready Compliance: Seamless alignment with FDA and international standards, supporting defect density metrics and versatile export formats (e.g., CycloneDX, SPDX, PDF, VEX).
- Proactive Risk Management: Continuous risk assessment and prioritization, enabling real-time monitoring of vulnerabilities and their impact on specific products.
Results
By integrating the Vigilant Ops SBOM Lifecycle Management platform, Bayer achieved significant improvements in cybersecurity and compliance, including:
- Operational Efficiency: The automation of SBOM processes led to significant time savings, allowing cybersecurity and compliance teams to focus on strategic initiatives.
- Enhanced Transparency: Bayer strengthened stakeholder confidence by providing comprehensive, real-time visibility into software components and potential risks.
- Strengthened Industry Leadership: By prioritizing SBOM transparency and security, Bayer continues to set a high standard for software supply chain security in the life sciences industry.
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"At Bayer, ensuring the security and transparency of our software supply chain is a top priority. Partnering with Vigilant Ops allowed us to automate and streamline our SBOM processes, giving us a clearer view of vulnerabilities while ensuring compliance with evolving global regulations. Their platform has been instrumental in helping us maintain our reputation as a cybersecurity leader in the healthcare space."
