Validating laboratory tests

Watch Related Videos Clinical labs must comply with the Clinical Laboratory Improvement Amendments (CLIA) to be certified to perform testing on human specimens.

Labs involved in development of new tests and technologies and in clinical studies also must comply with FDA regulations.

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It must ensure the integrity of the device from the point of manufacture to the point of final use.In addition, packaging often has a direct function in the application of the treatment; for example, it may act as a fixture or a dispenser.Like other life sciences industries, labs invest heavily in research and development of new technologies.Most of all, labs must ensure the quality, accuracy, and integrity of test results and other laboratory data.FDA-regulated labs maintaining electronic record-keeping systems must comply with 21 CFR Part 11.

Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements.

Stier Validation has always been part of the Hazard Analysis and Critical Control Point (HACCP) system, but it is an even greater issue in today’s food safety management systems.

Even though this has been required since “day 1,” it is surprising how many companies’ HACCP plans contain no validation data.

The packaging process is extremely important as well.

Regulatory authorities recognize the critical nature of a sterile barrier system.

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