validationiprosessin

Validationiprosessen is a structured set of activities intended to confirm that a product, process, or service meets defined requirements and user needs. The term is used in multiple contexts, including software development, manufacturing, and data governance, and may appear in different spellings depending on language. It emphasizes producing documented evidence that the item functions correctly in its intended environment.

The process typically begins with planning and scoping, followed by requirement validation, design validation, and performance validation. Planning defines objectives, acceptance criteria, resources, roles, and timelines. Requirement validation checks that stated needs are complete, unambiguous, and testable. Design validation ensures that the proposed solution can satisfy those requirements, while performance validation, testing, and trial runs provide evidence that the item operates under expected conditions.

Documentation and traceability are essential; records link requirements to tests, results, and approvals. Reviews, audits, and independent verification help reduce bias and increase credibility. The output is a validated artifact or system accompanied by documented evidence of compliance and a clear acceptance decision.

In regulated or safety-critical domains, validationiprosessen is closely aligned with standards such as ISO 9001, ISO 13485, GxP guidelines, or software-specific frameworks. Common challenges include incomplete requirements, changing scope, and resource constraints. Best practices emphasize early stakeholder involvement, iterative validation, risk-based prioritization, and explicit criteria for success.