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2. Clinical quality management system - Wikipedia

   en.wikipedia.org/wiki/Clinical_Quality...

   Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...

3. Regulatory affairs - Wikipedia

   en.wikipedia.org/wiki/Regulatory_affairs

   Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...

4. Validation (drug manufacture) - Wikipedia

   en.wikipedia.org/wiki/Validation_(drug_manufacture)

   Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

5. QA/QC - Wikipedia

   en.wikipedia.org/wiki/QA/QC

   QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations.

6. Biomedical engineering - Wikipedia

   en.wikipedia.org/wiki/Biomedical_engineering

   This requires that a quality system shall be in place for all the relevant entities and processes that may impact safety and effectiveness over the whole medical device lifecycle. The medical device engineering area is among the most heavily regulated fields of engineering, and practicing biomedical engineers must routinely consult and ...

7. Process analytical technology - Wikipedia

   en.wikipedia.org/wiki/Process_analytical_technology

   Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).