Pharming digitizes lane risk assessments to support global lane expansion

As Pharming, an innovative biopharmaceutical company focused on rare-disease treatments, expanded into new markets, manual lane risk assessments became a bottleneck. Excel-based FMEA files were slow, inconsistent, and difficult to scale. Assessments often took weeks and were scattered across teams, limiting visibility and audit readiness.

Pharming needed a scalable, auditable, and standardized approach that could support growth without compromising quality.

Pharming defined three clear requirements for its future risk management framework:

• Compliance readiness: A clear, auditable, GxP-aligned process
  

• Higher quality: Consistent, data-backed risk assessments
  

• Agility for change: A scalable framework for new lanes and logistics partners

To achieve this, Pharming partnered with Validaide to redesign its lane risk assessment process and establish a digital foundation for long-term growth.

Together, they implemented a fully digital lane risk assessment workflow aligned with Pharming’s quality system.

The impact was immediate and measurable. Lane risk assessments became 75% faster, each department worked from the same single source of truth. QA teams were always prepared for audits. By removing the limits that they had become used to, Pharming was able to become more efficient without adding headcount or relying on external consultants.

Pharming continues to scale its digital risk management framework with Validaide by onboarding additional 3PLs (third-party logistics), expanding into new markets, and incorporating sustainability metrics. As they become more digitally mature, they’re moving beyond reactive LRAs to proactive, data-driven risk management.