Picture a speciality manufacturer in the UK with two production sites: a growing contract manufacturing business and plans to bring its first commercialised product to market.
Its quality team decides it’s time to replace a patchwork of spreadsheets and ageing point solutions.
The shortlist is led by the same enterprise quality and regulatory platform used by the world's largest medtech and pharmaceutical companies.
The logic seems sound: if it satisfies global inspectors who visit a top 20 medtech or pharma company, it will satisfy those same inspectors for this UK-headquartered company too.
Three years later, the new quality management system rollout is still unfinished. Validation has taken far longer than planned, delivery costs have run to several times the original budget and the organisation is using a limited amount of the functionality it licensed.
The quality team, already stretched, now spends a meaningful share of its week managing software instead of improving processes and supporting product innovation.
This is rarely a story of poor execution, notes Mike King, Senior Director, Product and Strategy, Quality, Regulatory, Safety and Detect, at IQVIA.
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