Software

EMdi OS

The EMdi OS software powering the EMMA system from Microtechnix delivers robust, compliant, and user-centric functionality tailored for microbiology QC environments. Designed according to ALCOA+ principles, the software ensures the highest standards of data integrity and compliance with 21 CFR Part 11 and Annex 11 regulations. EMdi OS supports secure user login options through Active Directory or local access, with tiered account types, including Administrator, Key User, and Operator roles. Advanced features include a comprehensive audit trail for tracking all user actions and system changes, as well as live triaging powered by Vision AI to classify results as positive (growth) or negative (no growth) in real time. Additionally, the EMdi Viewer software enables users to analyze and annotate results seamlessly. With full LIMS integration, EMdi OS facilitates streamlined operations, ensuring compliance, efficiency, and precision for modern QC laboratories

 

 

Redefining Microbiology QC with Data Integrity and Precision

A next-generation software platform designed to empower microbiology quality control professionals with compliance, efficiency, and advanced AI-powered insights. Built to meet 21 CFR Part 11 and Annex 11 requirements, EMdi OS simplifies workflows, enhances data integrity, and delivers increased reproducibility and precision at every step of your QC process. Integrated Robotic Process Automation (RPA) automates repetitive tasks, accelerating processes and improving overall operational efficiency.

How it works

EMdi OS is designed to simplify and automate microbiology QC workflows while maintaining high standards of compliance and accuracy. The system integrates Vision AI to provide real-time analysis, allowing microbiology professionals to efficiently manage and review results. With customizable roles, predefined jobs, and intuitive sorting features, EMdi OS streamlines the entire process from sample acquisition to final review. Below are the key functionalities of how the system works:

  • User Roles: Define access levels for Administrator, Key User, and Operator to ensure appropriate control and security.
  • Predefined Jobs: Select from pre-configured testing protocols, tailored to specific testing needs.
  • Petri Dish Selection: Choose the number of Petri dishes to analyze for each job.
  • One-Click Start: Hit the play button to begin the imaging and analysis process.
  • Vision AI Analysis: Acquire high-resolution images and use AI to perform real-time positive/negative analysis on the results.
  • Sorting Results: Physically and digitally sort Petri dish results based on the AI’s analysis into positive and negative categories.
  • Human Review for Positives: Positive results always require human review to ensure the highest accuracy and compliance.

 

This combination of automation, AI analysis, and human oversight maximizes the efficiency, reproducibility, and precision of microbiology QC processes.

Core features of EMdi OS

  • Data Integrity & Compliance: Ensures adherence to ALCOA+ principles, 21 CFR Part 11, and Annex 11 regulations.
  • AI-Powered Vision Analysis: Real-time triaging of results with automated positive/negative classification.
  • Audit Trail: Full traceability of user actions and system changes, supporting compliance audits.
  • RPA (Robotic Process Automation):
    • Automates routine and manual tasks within the microbiology QC workflow, such as data entry, sample tracking, and report generation.
    • Reduces human error, increases operational efficiency, and accelerates data processing for faster decision-making.
    • Enables teams to focus on higher-value tasks like data analysis and decision support, improving throughput and reliability.
  • Customizable User Roles: Supports multiple user levels, including Administrator, Key User, and Operator, ensuring access control and accountability.
  • LIMS Integration: Seamlessly integrates with existing Laboratory Information Management Systems (LIMS), streamlining data flow and reporting.
  • EMdi Viewer: Powerful result analysis and annotation tools for greater insight into microbiology QC results.

Version Freeze & Locked State AI for Quality Assurance

To ensure the highest levels of quality assurance (QA) and maintain compliance, EMdi OS incorporates a Version Freeze and Locked State AI feature. Once the Performance Qualification (PQ) has been completed, the software and AI models are locked to prevent any further updates or changes. This guarantees that the system remains consistent and fully validated throughout its use in regulated environments. Key features of this process include:

  • Version Freeze: After PQ is finalized, EMdi OS software enters a version freeze, meaning no software updates, modifications, or changes can be made unless explicitly authorized. This ensures that the system used in production remains the same as the one that was validated.
  • Locked State AI: The AI algorithms are also locked in a validated state, preventing any automatic or unauthorized updates to the AI models. This ensures that the AI’s analysis and classification results remain consistent and reproducible, maintaining compliance with regulatory standards.
  • Compliance Assurance: The version freeze and locked state AI align with industry regulations like 21 CFR Part 11, ensuring that both the software and AI functionality meet strict data integrity and audit trail requirements.

 

By implementing Version Freeze and Locked State AI, EMdi OS ensures that once the system is validated, it will continue to operate with the same functionality, providing confidence in its performance and compliance throughout its lifecycle.

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