![]() The term “instrument” in this blog refers to any apparatus, equipment, instrument or instrument system used for analyses. In order to ensure your organization is compliant with regulations, let’s explore the relevant details regarding analytical instrument qualification and documentation. Lack of (or insufficient) qualification procedures and/or documentation are in fact frequently cited deviations in FDA inspectional observations and warning letters. During an inspection, the FDA will expect to see definitive evidence that instrument qualification schedules effectively control your manufacturing and testing processes. This evidence helps to ensure confidence that products being produced by the manufacturer are both safe and efficacious for public consumption.īecause of their potential for impacting product quality, laboratory instruments are key targets of FDA inspections. ![]() Laboratories operating in regulated environments are required to conduct instrument validation tests in order to produce documented evidence that instruments are fit for intended use and operate in a controlled manner to produce accurate results. These instruments run the gamut from simple apparatus to complex systems that combine a metrological function with software control. Analytical instruments provide important scientific data about manufactured products that serves to ensure that they meet specifications. ![]()
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