valideringsarbetet
Valideringsarbetet is the systematic and documented effort to establish that a product, process, or system fulfills its intended use in its operating environment and produces results that are reliable and meet defined requirements. It is central in regulated sectors such as pharmaceutical production, medical devices, food safety, and chemicals, and is also applied in software development and IT systems. The goal is to provide evidence-based assurance that outputs are reproducible and compliant with user needs and established standards.
The validation lifecycle typically includes planning, risk assessment, design of validation activities, execution, documentation, and review.
A key feature is the use of a risk-based approach to determine what needs validation and to
Valideringsarbetet also involves ongoing monitoring and revalidation when processes or environments change, ensuring continued suitability and