valideringsmål

Valideringsmål, or validation goals, refer to the explicit objectives set for validation activities aimed at demonstrating that a product, process, or system fulfills its intended use and complies with defined requirements. They are typically articulated in a validation plan and guide the selection of methods, acceptance criteria, and evidence required to judge performance.

The primary purpose is to manage risk by providing documented evidence that the item operates safely, effectively, and consistently under expected conditions. Validation goals also support regulatory compliance, quality assurance, and user confidence.

Applications span multiple sectors: pharmaceutical manufacturing and GxP environments; software and IT systems; laboratory methods and analytical procedures; equipment qualification and manufacturing processes; and data processing pipelines.

Key elements include defining the intended use, specifying acceptance criteria, choosing validation methods, planning experiments or tests, collecting and evaluating evidence, and issuing a validation report. Re-validation or re-testing is required when changes occur or after significant deviations.

Valideringsmål are distinct from verification; validation asks "Are we building the right thing?" while verification asks "Are we building it correctly?" Validation typically requires traceability to user needs and regulatory standards, and produces formal documentation such as validation plans, protocols, and summary reports.

Standards and guidance often referenced include GMP/GxP frameworks, ISO 9001, ISO 13485, and software validation standards. The concept is central to quality management and regulatory compliance across industries.