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Quality Metrics - Q-Met Tool by CCS

Quality metrics are used throughout the pharmaceutical industry to monitor quality systems and processes and drive continuous improvement efforts in drug manufacturing. These 17 metrics will also be used by the US-FDA. The agency intends to request the submission of data from owners and operators of certain human drug establishments that are subject to inspections. The quality metrics program is expected to play an important role in addressing risk-based inspection scheduling and in the prediction, and potential mitigation, of drug shortages. Information must be submitted to FDA through the FDA Electronic Submissions Gateway (ESG).  FDA intends to provide additional technical details in a separate technical specification.

Source:

  1. US-FDA Guidance for Industry: Request for Quality Metrics
  2. US-FDA Technical Specification: Quality Metrics TECHNICAL CONFORMANCE GUIDE

Based on the Data Metrics and Technical Specification CCS has developed the reporting tool Q-Met, which comes with a full set of different features:

  • Data and Security Audit Trail - 21 CFR Part 11 compliant;
  • Data Validation (based on US-FDA validation rules);
  • Report Generator (incl. eDMS bridge) - PDF, XML and print-outs (controlled print-outs);
  • Gateway function (configurable) to FDA ESG;
  • Technical Specification according US-FDA, refer to [2.] - ready for implementation;
  • Automated calculations by Q-Met based on configuration;
  • Review and approval workflow, status and version control of all data objects;
  • Trending and logbook functions, revision control and compare functions;
  • Database storage (SQL-DB) and advanced security features (user management);
  • Automatic notifications and reminders;
  • Full version control of reports and data;
  • Easy data entry grid of Quality Metrics implemented including automated plausibility checks;
  • System validation package including templates and compliance services;
  • Easy integration of Q-Met to ERP, eQMS systems (e.g. deviation, CAPA, changes);
  • User-friendly interface and data entry forms including real-time reports and calculations; 
  • Enhanced search and query functions;
  • Configuration and training package for Q-Met.

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Q-Met Reporting Tool

  • Q-Met Dashboard

    Q-Met Reporting Tool -Dashboard View
  • Data Entry and Reporting

    Report Generator and Data Entry
  • Data Report Approval

    Data Validation and ES Approvals
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