SMART news
Precision Medicine
Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel therapeutics that integrate genomics and big data (genetic, clinical, molecular, diagnostic and environmental data) to detect pathogenic events at the genome level. Biologics, vaccines and highly selective NCEs are matched with disease targets validated by human genetics, to tailor medicines to patients. A human has 99.9% genetic similarity to the next human, 96% genetic similarity to a chimpanzee, 90% genetic similarity to a cat, and 60% genetic similarity to a chicken, and a banana. Fruit fly protein sequences have mammalian homologs while almost 75%…
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SMART quality & compliance
How is a system validated?
Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and vocabulary. A Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. Validation: Confirmation, through the provision of objective evidence, that the specified requirements for a specific intended use or application have been fulfilled. Qualification: Process to demonstrate the ability to fulfill specified requirements In general : Validation: For systems or general topics: process, systems, etc. Qualification: For single or individual items within your system, process: Equipment, lab methods, etc Below is a simplified process diagram on how to validate a system…
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