Overview[ edit ] Verification is intended to check that a product, service, or system or portion thereof, or set thereof meets a set of design specifications.
In the post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses. Verification can be in development, scale-up, or production.
This is often an internal process. Validation is intended to ensure a product, service, or system or portion thereof, or set thereof results in a product, service, or system or portion thereof, or set thereof that meets the operational needs of the user.
A set of validation requirements as defined by the user , specifications, and regulations may then be used as a basis for qualifying a development flow or verification flow for a product, service, or system or portion thereof, or set thereof.
Additional validation procedures also include those that are designed specifically to ensure that modifications made to an existing qualified development flow or verification flow will have the effect of producing a product, service, or system or portion thereof, or set thereof that meets the initial design requirements, specifications, and regulations; these validations help to keep the flow qualified.
This often involves acceptance of fitness for purpose with end users and other product stakeholders. This is often an external process. It is sometimes said that validation can be expressed by the query "Are you building the right thing? In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.
It is entirely possible that a product passes when verified but fails when validated. This can happen when, say, a product is built as per the specifications but the specifications themselves fail to address the user's needs. Activities[ edit ] Verification of machinery and equipment usually consists of design qualification DQ , installation qualification IQ , operational qualification OQ , and performance qualification PQ. DQ may be performed by a vendor or by the user, by confirming through review and testing that the equipment meets the written acquisition specification.
The typical example of such a case could be the loss or absence of vendor's documentation for legacy equipment or do-it-yourself DIY assemblies e. This kind of the DIY approach is also applicable to the qualifications of software, computer operating systems and a manufacturing process. The full scales of some equipment qualifications are even time dependent as consumables are used up i. Torres and Hyman have discussed the suitability of non-genuine parts for clinical use and provided guidelines for equipment users to select appropriate substitutes which are capable to avoid adverse effects.
Instead, the asset has to be recycled for non-regulatory purposes. Categories of validation[ edit ] Validation work can generally be categorized by the following functions: Prospective validation — the missions conducted before new items are released to make sure the characteristics of the interests which are functioning properly and which meet safety standards.
If any critical data is missing, then the work can not be processed or can only be completed partially. Some of the examples could be validation of: The most important and significant effects are tested. From an analytical chemistry perspective, those effects are selectivity, accuracy, repeatability, linearity and its range. Examples of these changes could be.