valideringsprocedures

Valideringsprocedurer, or validation procedures, are a structured set of activities and records used to demonstrate that a process, system, equipment, or method performs reliably within defined limits and meets predetermined acceptance criteria. They are a core part of quality management and regulatory compliance in industries where product safety, efficacy, or data integrity are critical. Validation is a lifecycle activity that typically requires documentation such as a validation master plan, validation protocols, and a validation report, and it often includes phases such as design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

Scope and lifecycle: Valideringsprocedurer cover a lifecycle from planning to execution and revalidation. Key components include the Validation Master Plan, Validation Protocols, Validation Reports, and change control. They address various domains such as process validation, equipment validation, cleaning validation, analytical method validation, and computer system validation (CSV). Revalidation is triggered by significant changes, deviations, or obsolescence, and ongoing monitoring ensures continued performance and data integrity.

Regulatory context and best practices: Validation activities align with quality and regulatory frameworks. In pharmaceuticals and biotech, GMP and ICH guidelines (Q7, Q8, Q9) are common, along with GAMP 5 for computer systems and 21 CFR Part 11 for electronic records. Medical devices may follow ISO 13485, and laboratories ISO 17025. Effective validation relies on risk-based planning, traceability from requirements to testing, independent QA review, thorough documentation, and robust deviation handling and CAPA to support audits and inspections.