validointijaksoon

Validointijakso is a project phase dedicated to validation activities. The term refers to the period during which a product, process, system, or service is evaluated to confirm that it meets defined requirements and fulfills its intended use. In Finnish, validointijaksoon describes entering or being within this phase.

Contexts where the term is used include software development, pharmaceutical manufacturing, medical devices, and industrial automation. In regulated industries, validation is a formal obligation under standards such as GMP, ISO 9001, and IEC 62304. Validation differs from testing: testing identifies defects, while validation assesses fitness for purpose and compliance with user needs and regulatory requirements.

Typical activities within a validointijakso include planning, execution, and documentation. This often involves developing a validation master plan, validation protocols, and final reports; installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for equipment; installation, commissioning, and change control; risk assessment, traceability matrices, and the collection of evidence to support a pass verdict.

Lifecycle and outcomes of the phase depend on the scope and risk of the system or process. The validointijakso aims to produce an approved state in which the product or process may operate within its validated use. It commonly requires formal sign-off by stakeholders and may trigger audits or require re-validation after significant changes.