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QUALITY MANAGEMENT SYSTEMS (QMS)
The pharmaceutical, medical device and biotech industry use quality management system. To successfully manage quality, the organizations use professional project management.
Documented guidelines helps the industry to develop technology to meet international regulations.
Exemples:
Regulations: FDA GMP, EU GMP, Japan GMP
Guidelines/Standards: ISPE, ICH, ISO 13485, ISO 9000
QTRACE AB FOCUS: Validation of the automated equipment and IT supporting manufacturing processes.
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