3 min read
In today's digitally integrated pharmaceutical ecosystem, vendor partnerships extend far beyond physical products or raw materials—they now involve data exchange, software systems, and cloud-based platforms. As a result, cybersecurity has become a critical component of third-party risk management, especially during vendor evaluations.
Failing to assess a vendor's cybersecurity posture can lead to data breaches, Regulatory non-compliance, IP theft, and significant reputational damage for pharmaceutical and life sciences companies. In this blog, we explore the growing cyber threats in pharmaceutical vendor relationships and outline strategies to mitigate them during supplier qualification and audits.
Why Cybersecurity Can’t Be an Afterthought in Vendor Evaluations
Pharma companies increasingly rely on third-party providers for manufacturing, logistics, clinical trials, Regulatory submissions, software platforms, and data analytics. These connections become a potential vulnerability if cyber controls are not adequately assessed and monitored.
Key Risks Include:
- Data breaches and intellectual property theft through insecure vendor systems.
- Ransomware attacks that halt operations or expose sensitive clinical and commercial data.
- Non-compliance with data protection regulations (e.g., GDPR, HIPAA) due to third-party failures.
- Lack of transparency and incident response coordination between vendors and clients.
These risks are amplified in regulated industries like pharma, where data integrity, traceability, and compliance are non-negotiable. Cybersecurity failures at the vendor level can lead to Regulatory action, product recalls, and damaged credibility.
Cybersecurity as a Core Element of Vendor Qualification
Traditionally, vendor evaluations in pharma have focused on GxP compliance, quality systems, and Regulatory history. In 2025, however, cybersecurity joins this list as a critical pillar of vendor due diligence, especially for vendors handling regulated data or integrated systems.
Key Cybersecurity Questions to Ask Vendors:
- Do you have a documented Information Security Management System (ISMS)?
- Are you compliant with global cybersecurity standards (e.g., ISO/IEC 27001, NIST, SOC 2)?
- How is data encrypted at rest and in transit?
- What access controls and authentication protocols are in place?
- Do you conduct regular penetration testing or vulnerability assessments?
- How do you manage incident response and notify clients during cyber events?
- What third-party tools or cloud platforms do you use, and how are they secured?
These questions help uncover the current state of a vendor’s cybersecurity framework and their culture of proactive risk management.
Integrating Cyber Audits into the Quality Audit Process
Cybersecurity evaluations can be incorporated into technical audits, remote assessments, or desktop reviews as part of the broader vendor qualification or re-qualification process. Here’s how pharma companies can embed cyber risk checks into existing audit frameworks:
- Add cybersecurity as a core chapter in your audit checklist, alongside GMP and documentation practices.
- Involve IT security experts or CISOs in the vendor assessment to evaluate technical controls.
- Request and review cyber audit reports, security certifications, and data protection policies.
- Ensure contract clauses around data security, breach notification timelines, and indemnification are clearly defined.
- Review how the vendor aligns with your internal cybersecurity policies to ensure compatibility and enforceability.
This integrated approach strengthens vendor oversight and demonstrates to regulators that the company has a comprehensive risk management system in place.
Cybersecurity in Regulatory Context
Regulators such as the FDA, EMA, and MHRA now emphasize data governance, data integrity, and risk-based approaches to vendor management. Recent guidance and inspection trends suggest that regulators expect companies to:
- Demonstrate awareness of digital risks across the supply chain.
- Maintain evidence of cybersecurity diligence during vendor selection.
- Include IT systems and cloud service providers in risk assessments and audits.
In addition, data protection authorities under frameworks like GDPR and HIPAA have strict expectations about how third-party vendors manage and safeguard personal and health data, especially when cross-border data transfers are involved.
Recommendations for Pharma Companies
To stay ahead of cyber risks during vendor evaluations, companies should:
- Establish a cross-functional vendor risk management team that includes QA, Regulatory, Procurement, and IT Security.
- Develop standardized cybersecurity assessment templates for vendors.
- Categorize vendors based on their digital exposure and criticality to prioritize cybersecurity reviews.
- Create a vendor cybersecurity scorecard to track compliance and identify high-risk partners.
- Perform periodic reassessments, especially if vendors upgrade systems, expand services, or suffer security incidents.
This proactive, structured approach reduces exposure to cyber threats and enhances transparency and collaboration between pharma companies and their vendor network.
Conclusion: Protecting Data is Protecting Patients
In an industry where data quality is synonymous with patient safety, overlooking cybersecurity in vendor relationships is no longer an option. By embedding cyber risk evaluation into the vendor qualification process, pharmaceutical companies can safeguard their supply chain, ensure Regulatory compliance, and maintain the integrity of their operations.
Strengthen Your Vendor Risk Strategy with Freyr Solutions
At Freyr, we help pharma and life sciences organizations manage end-to-end vendor compliance, including cyber risk assessments, digital audit checklists, and third-party oversight programs. Whether you’re qualifying a CMO or reviewing cloud-based vendors handling sensitive Regulatory data, Freyr provides tailored frameworks to ensure your partners meet both compliance and security expectations. Schedule a meeting to learn more about our services.
