Differences: Qualification, Validation, Verification, Calibration

Because of the manufacturing process roots of validation and its terminology, a distinction is sometimes made between qualification and validation.  Within the context of information systems the difference is that equipment and computer systems are qualified and computerized systems (including the controlled process) are validated.

Adding to the confusion caused by these terms with similar and overlapping meanings, different organizations mix the terms and definitions. Some organizations refer to verification as validation. Some define verification as dynamic testing and validation as static testing. Others refer to testing as verification or qualification. And others refer to qualification as validation.

The FDA provides us this definition:

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

It is important to bear in mind the purpose of the method to be validated. If the method is intended to serve as an alternative to a pharmacopeia method, then one must establish its equivalence to the pharmacopeia method in terms of the end result. Remember that the purpose of a method in the pharmacopeia is to determine whether the pharmacopeia article (for which a monograph exists in the pharmacopeia) satisfies the requirements in the monograph. If instead the purpose behind the use of a pharmacopeia method is for a purpose other than demonstrating that the article complies with monograph requirements, it is not necessary to perform the validation relative to the pharmacopeia results. This means that the validation should be conducted relative to the specific purpose for which it is intended. Also implicit in this is the use of a non-pharmacopeia method to determine something for which a pharmacopeia method exists, but again for purposes unrelated to satisfying a monograph requirement.

Wow, what a definition. Now the terms in a simple explanation:

Qualification is the action of proving that any equipment are properly installed, works correctly and leads to the expected results. The meaning of the word, validation, is sometimes broadened to incorporate the concept of qualification. If the instrumentation is not qualified, ensuring that the results indicated are trustworthy, all other work based upon the use of that instrumentation is suspect.

Qualification is a part of validation.

Qualifications tend to be smaller in scope than validations, tend to be less dynamic, and are frequently a subset of a greater validation initiative.

Validation provides documented evidence, to a high degree of assurance, that the computerized systems are accurately and reliably installed and can perform their functions as intended for use.

Validation is a lifecycle, and qualification is part of this lifecycle. Validation proves that the overall process works for a specific system. For example, the overall process needs to be validated for a specific application, while equipment hardware and software and the reference material used for the application should be qualified before or within the validation.

Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications.

Validations tend to be used when assessing something dynamic that is more prone to inadvertent change. They also tend to be larger endeavours including one or more subordinate qualifications (and/or verifications).

Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

Verification is intended to check that a product, service, or system (or portion thereof, or set thereof) meets a set of design specifications.

Verifications tend to be used when assessing something completed that is static and is not prone to inadvertent change.

Calibration is testing the equipment in relationship between indicated values by an instrument or system for measuring, recording and controlling and the corresponding known values of a reference standard. Therefore, limits for acceptance of the results of measuring should be established.