Service
Framework delivered; supporting procedures and templates in development
Scope
Accreditation, NGS introduction, ISO 17025 and automation
Year
2026 - ongoing
Result
Quality assurance framework for external IVD development
Brief
Alexion develops its clinical trial and companion diagnostic assays through external IVD partners. These collaborations provide specialist expertise but create complex interfaces between organisations, quality systems and regulatory responsibilities. Without a consistent governance model, ownership can become unclear and critical quality activities may be identified too late.
Alexion engaged me to establish a more consistent, proactive approach to planning, overseeing and managing externally developed IVD assays.
Approach
I mapped the end-to-end process for externally developed assays, identifying key activities, decision points and organisational interfaces across the development lifecycle. This analysis exposed gaps in Alexion’s existing QMS and clarified responsibilities between Alexion and its third-party IVD developers.
The framework moves quality planning upstream so that requirements, responsibilities and oversight are established at the outset of each collaboration rather than addressed later in development. The current implementation phase is developing supporting SOPs, procedures and working templates to embed this approach into routine practice.
Outcome
The delivered framework provides a standardised, scalable method for defining responsibilities, assessing requirements and setting appropriate oversight for external IVD programmes. Once embedded through the supporting procedures and templates now in development, it is intended to strengthen governance, accountability and readiness for the regulatory and quality demands of IVD development.
Result
Quality assurance framework for external IVD development
Scalable Quality Governance for Externally Developed IVD Assays
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