The biopharmaceutical industry is experiencing an unprecedented increase in demand, which is expected to continue for the foreseeable future. In response, companies are scaling up their operations as quickly as possible. However, since it is heavily regulated, rapid scale-up in biopharma is more...
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In good manufacturing practice (GMP) and other GxP’s, the term validation has a formal, specific meaning. In this context, validation is a quality management tool used to confirm that a process or a piece of equipment satisfies its intended purpose through the use of objective data.
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2020 has made the need for sound environmental monitoring practices clearer than ever. To help position your organization up for success in 2021, we’ve assembled our most popular articles from the past year, covering everything from mapping to validation to vaccine monitoring.
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Software validation, also called “computer system validation”, is a process that confirms a piece of software is designed for and satisfies its intended purpose. It involves reviews during software development or selection, and systematic installation procedures and testing during deployment....
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