• Enterprise Quality Management


Quality Management System Approach

Critical to your organization’s ability to demonstrate the management control required by the GxP regulations, the Quality Management System is an intense area of focus as part of FDA’s Quality Systems Inspection Techniques (QSIT) model, whether during an abbreviated or full inspection. 

Given this high level of regulatory scrutiny, the central hub of your management control system - an effective  Quality Management System - is critical to managing, identifying and preventing high risk events through automation, integration and collaboration with your enterprise applications.

Oftentimes, the common state of compliance is driven by:

  • Priorities determined by the latest crisis
  • Multiple, disconnected compliance solutions
  • A high level of regulatory exposure
  • Recurring, systemic issues resulting from systems which are ineffective at identifying & correcting true root causes
  • Resources pulled in many directions
  • Wasted time, resources and money

USDM’s approach emphasizes a “cradle-to-grave” systemic process to identify and measure the state of compliance across all functional areas of operations within a plant or facility for FDA regulated industries.

With years of direct, life sciences industry experience, our Quality Management Systems experts will guide you through our patented Quality Management Systems Maturity Model (QMSMM) process to determine the maturity level of your overall compliance framework and assist you in the design, configuration, implementation and validation of a complete quality management system integrated with your enterprise applications, which will advance you to a state of operational excellence. 

Benefits of Level 5 include:

  • A “best-in-class” compliance architecture in place
  • Resources allocated to the most important projects
  • Priorities aligned with corporate business objectives
  • Better return on time, resources and $$$ spent
  • Reduced regulatory exposure
  • Elimination of systemic, repeat issues

Collaborating with our other practice areas, we work with your team to utilize information systems such as SAP BusinessObjects and Cognos to integrate disparate data measurement across business applications to arrive at more meaningful metrics. As an example, most “stand-alone” Quality Management Systems provide reports of “static” data and identify the number of deviations or non-conformances by functional department on a weekly or monthly basis. 

Through the use of our business intelligence tools and integration with your ERP or MES systems, we can integrate the data and report the number of deviations or non-conformances as a percentage of the number of batch records or production orders executed during the period and analyze this data against prior periods to determine if performance is improving, declining or stagnating – a true quality indicator of enterprise performance.