Poster:

"Design Requirements for 21 CFR 11 Compliance and Manufacture 4.0 Readiness in a QC Microbiology Instrument"- Presented at the 2022 PDA Pharmaceutical Microbiology Conference

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Overview  

With regulatory authorities increased scrutiny on data integrity, it is critically important for pharmaceutical manufacturers to meet requirements. Current quality control (QC) processes are constrained by individual tests and waiting days for results, with subjective analysis, manual data generation, limiting the manufacturers confidence in data integrity and ability to rapidly release safe products. In addition to causing challenges around maintaining accurate (operator) user role management as well as having visibility into QC processes, system performance, and data results. 

 

The Growth Direct® System allows companies to meet ALOCA+ standards, and with the introduction of RMBNucleus™ Software, further enhances the Attributable, Complete and Available components. Through Active Directory integration, manufacturers can integrate the Growth Direct® System(s) with their email client to ensure proper users are performing the QC testing. A web-based LIMS integration ensures that Growth Direct® System(s) are effectively testing all samples that have been ordered through LIMS. The browser-based, manufacturer-hosted central portal maintains security standards while also providing visibility into all available QC test status across all systems. RMBNucleus™ Software further enhances companies’ efforts to meet ALCOA+ standards and enables manufacturers visibility into thousands of tests across multiple Growth Direct® Systems.  

 

Objectives

  • Highlight the enhancements associated with RMBNucleus™  Software
  • Show the impact RMBNucleus™  Software's new features have on data integrity in QC microbiology processes
  • Demonstrate the role of RMBNucleus™ Central Manager as a new component in the link between LIMS and Growth Direct®
  • Feature how RMBNucleus™ Central Manager is designed to increase Complete and Consist QC testing