Validierungsstufen
Validierungsstufen, often translated as validation levels or stages, refer to the distinct phases or steps involved in the process of confirming that a system, product, or process meets its intended requirements and functions as expected. These stages are crucial in ensuring quality, reliability, and compliance, particularly in regulated industries like pharmaceuticals, medical devices, and software development.
The specific number and nature of these validation stages can vary depending on the industry, regulatory guidelines,
Further stages often involve process validation, which confirms that a manufacturing or operational process consistently produces
The overall goal of these validation stages is to build confidence that the product or system will