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It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. [1]: "Decision Makers' Summary", [2] Regulatory agencies have recently begun to look at more fundamental quality metrics of manufacturers than just compliance with basic GMP regulations.
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control, and quality improvement. [1] Quality management is focused both on product and service quality and the means to achieve it.
Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. [8] Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). [9]
Billionaire entrepreneur and top adviser to President-elect Donald Trump, Elon Musk, touted that he has reaped the benefits of a controversial class of weight-loss drugs, after fellow top Trump ...
The company published "Modern Methods of Antiseptic Wound Treatment", a guide on how to do sterile surgery using its products, and in 1888, distributed 85,000 copies to doctors and pharmacists across the United States. [14]: 3–99 The manual was translated into three languages and distributed worldwide. [14]
A sponsor sends a feasibility questionnaire to the local research site. The Clinical Research Coordinator completes the form on behalf of the site to determine if the local site has the patient population, support staff, medical facilities, and equipment necessary to successfully carry out the study protocol.