What is a Regulated Environment

A regulated environment is any environment operating under defined control rules and standards that ensure valid and consistently high-quality results or products. Such regulations are usually set by various sources: the company itself, government authorities - such as the American Food and Drug Administration (FDA) - or other organizations responsible for product quality and standardization.

In the context of analytical laboratories, compliance with a regulated environment means that every operation involving data must be reproducible at any time. In Clarity, the following file types are considered data: methods (*.MET), chromatograms (*.PRM), calibrations (*.CAL), and sequences (*.SEQ). Each of these files includes its own Audit Trail, and both method and chromatogram files also store their complete history.

This manual is designed to guide Clarity users in configuring and operating the software in accordance with such regulatory requirements.