Validasjon

Validasjon is the systematic process of determining that a product, service, process, or dataset meets defined requirements and fulfills its intended use. It differs from verification, which checks whether something was built according to design. Validation asks whether the end result is suitable for its purpose, while verification focuses on the correctness of the steps taken to produce it. Validasjon is used across industries to reduce risk and increase confidence in outcomes.

Common applications include data validation in information systems, software validation to confirm that applications meet user needs, and process validation in manufacturing and life sciences. Data validation enforces data quality through checks on type, range, format, and business rules. In regulated sectors, validation is an essential part of quality assurance and regulatory compliance, with documentation proving that processes and systems consistently produce intended results.

Approaches range from plan-driven validation to risk-based methods. Key concepts include prospective validation (before deployment) and retrospective validation (using historical data). Validation can cover computer systems (computerized system validation), analytical methods, manufacturing processes, and predictive models. Evidence is gathered through testing, demonstrations, or analyses, and is organized into a validation report.

Typical workflow involves defining acceptance criteria, developing a validation plan and protocol, executing tests, collecting and analyzing evidence, and issuing an approval decision. When criteria are not met, corrective actions and revalidation are required. Revalidation may be triggered by changes, incident findings, or the passage of time to maintain compliance and trust in results. Documentation and traceability are central to the process.