By Jeff Kasoff
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.
Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.