Thursday, 31 May 2012

VALIDATION VS CALIBRATION






 VALIDATION VS CALIBRATION





              
CALIBRATION
VALIDATION
Calibration is a demonstration that, a particular
Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.

Validation is a documented program that provides high degree of assurance that a specific process, equipment, method or system consistently produces a result meeting pre-determined acceptance criteria.

In calibration performance of an instrument or device is comparing against a reference standard.

No such reference standards are using in validation program.
Calibration ensures that instrument or measuring devices producing accurate results.
Validation provides documented evidence that a process, equipment, method or system produces consistent results (in other words, it ensures that uniforms batches are produced).

Shall be performed periodically, to identify the ‘drift’ of the measuring device or equipment and make them accurate.

No such requirements. Shall be performed when changes or modifications happen to the existing system or once revalidation period is reached.

Shall be performed as per calibration SOP.
Shall be performed as per validation protocol.



3 comments:

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