White Paper

Steps To Implementing A Quality Management System (QMS)

Source: Advarra
Management audit iStock-1006625398

Across the life science industry, many development companies and research and development (R&D) organizations do not have a quality department or even a specific quality function in their early stages of development. Science and research-driven activities require a high degree of flexibility and may demand fast reviews of development stages – at times, even reconsideration of the development program or project termination. That environment does not seem to promote the acceptance for a quality function because it may impose bureaucracy, overly formalized processes, rigidity, and may be interpreted as an organizational burden, hindering the intended exploration and fast-paced development. But does it really?

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