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. Common activities are installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ), along with validation testing, method validation, and data validation. Timelines are guided by a Validation Master Plan and individual Validation Protocols, with results summarized in Validation Reports. All work is traceable to requirements and complemented by deviations, corrective actions, and change control.

A key feature is the use of a risk-based approach to determine what needs validation and to what extent. Documentation is essential to demonstrate compliance with standards such as GMP, GAMP, ISO 9001, or ISO 13485, and, in software, best practices for software validation are applied.

Valideringsarbetet also involves ongoing monitoring and revalidation when processes or environments change, ensuring continued suitability and performance. The activities are typically led by a Valideringsansvarig or QA function, with collaboration among engineering, production, IT, and quality assurance teams.