Regulatory & Industry Guidance

Analytical Instrumentation | IVT

I. Introduction   In order to ensure the quality and reliability of data produced by a laboratory, it is necessary to use a systematic method of qualifying and calibrating the instruments in a way that is appropriate for the type of instrument and which takes the type of use into consideration. Because reliable data is a key component of GMP, it is covered throughout global regulations and guidelines.   II. Major Regulatory Guidelines   Code of Federal Regulations Title 21 Part 211 Section 160 Subpart I: Laboratory Controls   The calibration of instruments, apparatus, gauges,...

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