SMART quality & compliance
Data Integrity: Risks and Solutions
To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall documentation of every GxP-relevant activity performed during the whole product life cycle. The FDA recommends that this documentation should be based on the ALCOA principles. To guarantee Attributable, Legible, Contemporaneous, Original and Accurate documentation, life-science companies increasingly seek experts for advice. Focusing on data integrity by kicking off respective projects and hiring consulting experts within this field…
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SMART quality & compliance
Implemention a Smart Quality Management System
– “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” ~William A. Foster Implement A Quality Management System Effectively and Efficiently Today’s fast changing business environment demands from a company increased flexibility, openness and security. Stakeholders expect transparency, highest quality and compliance ensuring product quality, patient safety and data integrity. In fact, companies operate in a highly competitive environment, which ruthlessly challenges their activities. Businesses need to stay ahead of the opposition. In order to achieve it, they must deliver products…
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