Valideringens

Valideringens is used in Scandinavian contexts to refer to the practice or domain of validation. In Swedish and Norwegian, validering means validation, and valideringens is the definite/genitive form that appears in phrases such as valideringens syfte (the purpose of validation). The term is used to describe both the overarching concept of validating products, processes, or data and the organized activities that accompany it.

Valideringens aims to establish that a product, system, or process meets specified requirements and intended use, and is fit for its purpose. It seeks evidence of performance, safety, reliability, and regulatory compliance, typically through planned experiments, testing, and documentation.

In practice, valideringens spans multiple domains. In manufacturing and pharmaceuticals it is closely linked to regulatory validation, including validation of facilities, equipment, processes, and computer systems. In software and IT, it covers software validation and systems validation according to standards such as GAMP and ISO 9001/ISO 13485. In clinical research, it supports the demonstration that measurement methods and procedures produce accurate, repeatable results.

A typical validering process includes planning (a valideringsplan or validation plan), defining user requirements, executing tests or simulations, collecting evidence, and producing a validation report. Key concepts include installation qualification, operational qualification, performance qualification, and ongoing change control.

Valideringens is influenced by risk management, quality culture, and lifecycle thinking, with trends toward continuous validation, real-time monitoring, and documentation automation. It emphasizes traceability and reproducibility to support decision making and compliance.