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Design Qualification for Analytical Instrumentation

The purpose of Design Qualification (DQ) for analytical instrumentation is to ensure that the instrument's design aligns with regulatory requirements, user needs, and operational specifications. It is essential to qualify that Commercial off-the-shelf (COTS) instruments are suitable for their intended applications and that the manufacturer has adopted a quality system that ensures reliable equipment. Users should also assess the manufacturer's capabilities for installation, services, and training support.

DQ shall encompass the following:

  • Regulatory Compliance: Ensuring that the instrument's design complies with cGMP and other relevant regulatory standards and guidelines.
  • User Requirements: Verifying that the instrument's design aligns with the User Requirements Specification (URS) and meets user needs and expectations.
  • Functional Specifications: Confirming that the instrument's design aligns with functional specifications, including accuracy, precision, sensitivity, and other key performance criteria.
  • Risk Assessment: Identifying and mitigating potential design-related risks that could impact safety, quality, or compliance.
  • Documentation Review: Thoroughly reviewing design documentation, such as schematics, drawings, and technical specifications, to ensure accuracy and completeness.

DQ plays a critical role in the instrument's lifecycle, focusing on the design and development stages to proactively prevent issues that may arise during later qualification and validation phases.