Validierungstätigkeiten

Validierungstätigkeiten, often translated as validation activities, are a systematic process of establishing documented evidence that a system, process, or product consistently meets its predetermined specifications and quality attributes. This concept is particularly crucial in regulated industries such as pharmaceuticals, medical devices, and food production, where deviations can have significant consequences for public health and safety. The core purpose of validation is to ensure reliability, consistency, and compliance with established standards and regulatory requirements.

The validation process typically involves several stages. Initial planning defines the scope, objectives, and methodology for the validation effort. Then, installation qualification (IQ) verifies that the system or equipment has been installed correctly according to specifications. Operational qualification (OQ) confirms that the system operates as intended within its defined operating ranges. Finally, performance qualification (PQ) demonstrates that the system consistently performs as expected under actual operating conditions and produces results that meet predetermined specifications.

Validation activities are not a one-time event but an ongoing process. Periodic revalidation may be necessary after significant changes to the system, process, or equipment, or at predetermined intervals to ensure continued compliance. The evidence gathered during validation activities is meticulously documented, forming a critical part of the overall quality management system. This documentation serves as proof that the system is fit for its intended purpose and complies with all relevant regulations.