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Change Control - Continuous Quality Improvements in FDA and ISO Environments
In highly regulated environments, any changes to equipment, materials, facilities, design, processes, packaging/labeling, computer systems, documentation, etc. pose a potential risk to public health and safety. But change is inevitable, which is why change control is such a critical component of FDA and ISO compliance, and the focus of several regulations and standards. This white paper looks at the change control requirements imposed on med device, pharmaceutical and manufacturing companies, and how to overcome the challenges inherent in maintaining a state of control.
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Bringing life changing products to more people sooner.
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