QUALITY ANALYTICS


We leverage our deep expertise in manufacturing and business intelligence along with our advanced capabilities in analytics to help our Life Science clients maintain organizational awareness of the current state of manufacturing quality.  By identifying and enabling consistent evaluation of key performance indicators (KPIs), we enable direct access to key quality signals and ensure uninterrupted supply of needed medicines.  Scalable monitoring processes are designed to support evolving pipeline production demand and comply with new FDA and Global Health Authority requirements for “measuring what you manage”.  Streamlining the management of related data improves data integrity and greatly simplifies the reporting process.

QUALITY ANALYTICS SOLUTIONS


Quality analytics measures are increasingly being recognized by Life Sciences firms and Global Health Authorities as key tools for ensuring uninterrupted supply of medicines and monitoring compliance across industry supply chains.

The United States FDA is pursuing industry standards for quality metrics and the need to collect, integrate and manage manufacturing data has become paramount to maintaining a strong compliance posture. Regulators intend to rely on these metrics to create a more flexible and rationalized review and inspection system.  Firms able to manage this process efficiently and effectively stand to benefit from a more proactive, risk-based surveillance scheme with a minimum of additional overhead.


Paragon takes an integrated approach to Quality Analytics that includes industry best practices, Health Authority priorities, critical metrics and Paragon’s target state point of view that delivers; decision support capabilities, business process design and a robust analytics foundation in the form of:

  • An easily accessible platform to allow monitoring and pro-active management of quality-related KPIs, data sets and metrics in support of continuous improvement and product availability.
  • Seamless integration of data from disparate sources and systems, enabling strategic visualization and streamlined processes for routine reporting and addressing regulatory requests.
  • Flexible and scalable processes to accommodate evolving global operations and quality systems.
  • Quality Business processes and solution architecture that set the foundation for Health Authority compliance

 

Quality Operations teams have a critical need to proactively monitor product quality over time, leveraging available data to drive continuous improvement.  Tools are needed which help identify potential issues and risks before the cost and impact become unacceptable.   The solutions need to be tailored to the unique needs of the products and supply chain and provide sufficient granularity to facilitate further investigation and decision-making.  They must also enable simplified reporting of this information both internally and to health authorities.  Internal IT support teams and services will need to be integrated into the ultimate solution.

We provide consulting services that enable companies to: 

  • Ensure that quality-critical data is accessible, and in a readily sortable, reportable, and interpretable format to facilitate interactions with regulators.
  • Develop periodic internal and Health Authority product quality reports with great efficiency.
  • Establish processes and systems to proactively monitor product quality and take appropriate internal and regulatory action.
  • Sustainably reduce quality costs and position Quality as a competitive advantage.

HOW OUR QUALITY ANALYTICS SOLUTIONS DELIVER

Successful companies invest in analytical capabilities to support the following business drivers:  launch of new products, introduction of new facilities, processes improvements, technology monitoring, growth of the supply chain, expanding markets, complexity of specialty business models, internal manufacturing and external supplier/partner integration. Paragon’s experts work with your Quality Analytics Group to:

  • Understand and define your Quality target state and opportunities for innovation.
  • Prototype key capabilities and processes with real data to ensure a full understanding of the business requirements.
  • Plan and design solution architectures that map to your foundation and expected growth
  • Analyze business and technical capabilities needed and design an optimal solution set that fits your organization and can scale for demand.
  • Facilitate organizational adoption and capability pull-through via targeted training and, change management, collective team support and use case optimization.
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