QC/QA

This section of the documentation describes the Quality Control and Quality Assurance (QC/QA) framework within the AssayNet LIMS, designed to ensure the accuracy, reliability, and compliance of laboratory results. The QC/QA process is organized into five distinct sections, each focusing on specific areas of quality control.

  1. Preparation: These controls are applied during the sample preparation phase, aiming to monitor and mitigate any risks of contamination or procedural errors.
  2. Analysis: These checks validate the accuracy and precision of analytical methods, ensuring that results are consistent and within acceptable limits.

    Note: Duplicates and Replicates are not set up within the QC/QA menu. Instead, these standards are configured within the analysis code Q.C. Options section, where their control parameters can be specified according to client requirements. For more information, see Set up QC Analysis Code Options.

  3. Instrument: Dedicated to maintaining the performance and calibration of analytical instruments, this section ensures that equipment meets rigorous standards for accuracy and reliability.
  4. General: This section encompasses broader quality control measures applicable to various aspects of the laboratory process, enhancing overall data integrity.
  5. Compliance: This area ensures adherence to relevant industry regulations, guidelines from government authorities, and internal standards, reinforcing the credibility and regulatory compliance of laboratory operations.

The section guides users on how to add each QC type within the AssayNet LIMS, providing step-by-step instructions for setting up control limits tailored to meet each client's specific requirements. This is further supported by a dedicated QC Calculations section, which details the mathematical formulas and parameters used to determine allowable variance and control limits across different QC types. These calculations are configured within the screen Q.C. Option, where the control parameters are input to ensure that each QC type is aligned with operational needs and compliance standards.

The AssayNet LIMS is designed to meet ISO standards for laboratory operations, providing a robust quality framework that supports both operational efficiency and regulatory compliance.