Verified - Categories of Verification and Validation

Categories of Verification and Validation

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. Some examples could be legislative rules, guidelines or proposals, methods, theories/hypothesis/models products and services
  • Retrospective validation – a process for items that are already in use and distribution or production. The validation is performed against the written specifications or predetermined expectations, based upon their historical data/evidences that are documented/recorded. If any critical data is missing, then the work can not be processed or can only be completed partially. The tasks are considered necessary if:
    • prospective validation is missing, inadequate or flawed.
    • the change of legislative regulations or standards affects the compliance of the items being released to the public or market.
    • reviving of out-of-use items.
Some of the examples could be validation of:
  • ancient scriptures that remain controversial
  • clinical decision rules
  • data systems
  • Full-scale validation
  • Partial validation – often used for research and pilot studies if time is constrained. The most important and significant effects are tested. From an analytical chemistry perspective, those effects are selectivity, accuracy, repeatability, linearity and its range.
  • Cross-validation
  • Re-validation/Locational or Periodical validation – carried out, for the item of interest that is dismissed, repaired, integrated/coupled, relocated, or after a specified time laps. Examples of this category could be relicencing/renewing driver's license, recertifying an analytical balance that has been expired or relocated, and even revalidating professionals. Re-validation may also be conducted when/where a change occurs during the courses of activities, such as scientific researches or phases of clinical trial transitions. Examples of these changes could be
    • sample matrices
    • production scales
    • population profiles and sizes
    • out-of-specification] (OOS) investigations, due to the contamination of testing reagents, glasswares, the aging of equipment/devices, or the depreciation of associated assets etc.
In GLP accredited laboratories, verification/revalidation will even be conducted very often against the monographs of the Ph.Eur., IP to cater for multinational needs or USP and BP etc to cater for national needs. These laboratories must have method validation as well.
  • Concurrent validation – conducted during a routine processing of services, manufacturing or engineering etc. Examples of these could be
    • duplicated sample analysis for a chemical assay
    • triplicated sample analysis for trace impurities at the marginalized levels of detection limit, or/and quantification limit
    • single sample analysis for a chemical assay by a skilled operator with multiplicated online system suitability testings

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