Effective IT quality management ensures stable and reliable services. This not only enables you to comply with relevant regulations (e.g. FDA Title 21 CFR Part 11 and Part 820, ISO 13485 and ISO 62304, AMWHV or EU GMP Annex 11), but also increases the efficiency of your business processes and the value contribution of your IT.
An efficient qualification strategy provides not only ensures compliance with relevant regulations, but also allows you to increase the value contribution of your IT through lean processes and stable services while optimizing your costs.
Our areas of expertise
In a recent project we increased the efficiency, quality and consistency of Project Quality Management (PQM) in a global pharmaceutical group.
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Head of Compliance & Group CEO