Mike King, senior director of product & strategy, quality, regulatory, safety & detect at IQVIA, explores how the growing role of combination products and companion diagnostics in pharmaceutical portfolios is driving the need for quality and regulatory platforms tailored to each organisation.
Picture a specialty pharmaceutical manufacturer with 300 employees and two production sites. Its quality team is preparing for growth, including a new biologic, its first prefilled syringe presentation and the potential addition of a new contract manufacturing client. To support that growth, the team decides it is time to replace a patchwork of spreadsheets and ageing quality management technology point solutions. The shortlist is led by the same enterprise quality and regulatory platform used by the world's largest pharmaceutical companies. The logic seems sound: If it satisfies inspectors at a top-20 pharma company, it will satisfy them here.
Three years later, the rollout is still unfinished. Validation has taken far longer than planned, the total cost of ownership has run higher than the original budget, and the organisation is using less functionality than it licensed because it doesn’t need those unused features. The quality team, already stretched, now spends a meaningful share of its week administering software instead of improving processes.
This is rarely a story of poor execution. It usually begins with a flawed assumption: that technology built for the largest life sciences organisations is the benchmark every manufacturer should aspire to, regardless of size, product mix or regulatory profile. In reality, the secret to success is in right-sizing the quality management solution to the company’s product ranges, geographic footprint, risk profile and business performance drivers.
