Tuesday , October 27 2020
Calibration-vs-Validation

Difference between Calibration and Validation

Calibration and validation both are related to the measurement devices, equipment, process, and system. These terms are often confusing. By reading this article your confusion regarding Calibration and validation may erase.

Calibration vs Validation

Definitions of Calibration and Validation

Calibration is a process or action that compares the measurement values of a measuring device or equipment against a reference standard and certifies the measurement accuracy.

On the other hand, validation is a detailed documented process of confirming that the equipment or machine is installed correctly, operating effectively, and performing without any error.

In other words, validation is a systematic study that helps to verify that the equipment, facilities, processes and, systems perform the job adequately and consistently as specified.

The simple meaning of calibration and validation

Calibration simply means system performance checking. While validation means a method of analysis performance checking.

Why these are necessary?

Calibration is an operation to confirm that the equipment or measuring device is performing accurately. Whereas, validation is an operation to confirm that the analytical method is performing accurately. Calibration provides: Is equipment or measuring device accurate? Validation provides: Is equipment or measuring device system function satisfactorily?

Balance calibration

Image of Electronic balance calibration and Reference standard (Weight)

Purpose of Calibration and Validation

Calibration is done to nullify or remove the deviation by comparing with a reference or know standard. While validation is done to verify the consistency of predictable results of the method, process, or procedure.

Benefits of Calibration and Validation

Benefits of Calibration

Calibration is done to ensure:

Benefits of Validation

  1. It will minimize rejection loss
  2. Reduction in utility cost
  3. Help timely corrective action
  4. Assure consistent production performance
  5. Ensure achievement of quality goals
  6. Reduce extensive finished product testing
  7. Easier maintenance of the equipment.
  8. Allow parametric release
  9. Sort out the main risk of production liability
  10. More rapid automation

Operational interval

Calibration is done periodically and frequently than validation. For example, most of the electronic balance is calibrated quarterly. While validation is done periodically and less frequently than calibration.

The necessity of reference standard

Calibration of any equipment is done by comparing with a reference standard. While in validation, there are no known standard or reference standards used.

How Calibration and Validation are executed?

Calibration will be executed according to calibration SOP. While validation will be executed according to the validation protocol.

Summary of the difference between Calibration and Validation

Features Calibration Validation
Definition Calibration is a process or action that compares the measurement values of a measuring device or equipment against a reference standard and certifies the measurement accuracy. Validation is a detailed documented process of confirming that the equipment or machine is installed correctly, operating effectively, and performing without any error.
Simple meaning It is system performance checking. It is a method of analysis performance checking.
Objectives To nullify or remove the deviation by comparing with a reference or know standard. To verify the consistency of predictable results of the method, process, or procedure.
Uses To confirm that the equipment or measuring device is performing accurately. To confirm that the analytical method is performing accurately.
Operational Interval Calibration is done periodically and frequently than validation. Validation is done periodically and less frequently than calibration.
Reference Standard It is done by comparing with a reference standard There are no known standard or reference standards used.

 

Procedure Executed according to calibration SOP. Executed according to the validation protocol.
Benefits To ensure:

  • Specificity
  • Linearity
  • Accuracy
  • Sensitivity
a. It will minimize rejection loss

b. Reduction in utility cost

c. Help timely corrective action

d. Assure consistent production performance

e. Ensure achievement of quality goals

f. Reduce extensive finished product testing

g. Easier maintenance of the equipment.

h. Allow parametric release

i. Sort out the main risk of production liability

j. More rapid automation

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