A comprehensive User Requirements Specification (URS) acts as the backbone of your cleanroom implementation. It defines the specific needs and expectations of your operation, ensuring that your chosen cleanroom solution accurately meets these requirements. A robust URS should thoroughly consider aspects such as: * The nature of the processes taki
Confirming Cleanroom Suitability Through Robust Design Qualification (DQ)
Robust design qualification (DQ) is a critical step in establishing the suitability of a cleanroom for its intended use. This thorough process involves a systematic evaluation of the cleanroom's structure to ensure it meets all relevant requirements and standards. DQ steps typically include reviews of engineering drawings, simulations, and risk ass