FDA is leading the movement toward the use of standard quantitative measures to monitor manufacturing quality across the industry and enable a next-generation, risk-based inspection system. A “quality scorecard” approach is being considered that would allow comparison of peer firms to industry averages and expectations.
Beyond meeting the minimal compliance requirements to collect and share relevant data, the right approach to integrating and managing manufacturing data can also enable higher levels of performance by identifying signals in near-real-time and recognizing trends of concern to avoid future problems. Our solutions promote site- and product-specific analysis capabilities and unique area decision support to enable:
- Enhanced compliance with evolving regulations and data integrity standards, including development of critical reporting capabilities and mechanisms for sharing metrics data with FDA and other regulators easily.
- Visualization of key manufacturing insights allowing both rapid response to detected problems and predictive power to promote continuous improvement.
- Avoidance of quality-related interruptions of drug supply by allowing monitoring of manufacturing and support-related functions, including user-defined alerts and notifications, throughout the product lifecycle.
- A reduced regulatory burden more proportionate to an efficiently and effectively managed metrics program with a minimum of additional overhead.
We are typically engaged by Quality leaders who are interested in taking a data-driven approach to proactively reduce manufacturing risks and ensure compliance. To do so requires identifying the true KPIs and extracting the real value of data contained in multiple sources or not adequately captured. Integrating data and systems enables these leaders and their teams with strategic visualization, streamlined processes for reporting and timely decision-making.
Such leaders and their teams benefit from tools such as:
- Integrated, secure Quality Dashboards that can be tailored to your needs, with drill-down capabilities to understand root cause and drive strategic resource allocation
- Flexible and scalable processes to address evolving global operations and key quality systems indicators including OOS and batch failure rates, complaints, CAPA effectiveness, APQR preparedness, etc.
- Solutions tailored to the unique demands of your products and supply chain and simplified reporting both internally and in line with the latest health authority requirements
Our life science quality and information management experts will use their advanced competencies and deep domain knowledge to help you by:
- Managing the project through planning, analysis, business design, and implementation phases while enabling multi-stage deployment based on functional capabilities and priorities.
- Clearly defining requirements and utilizing an iterative and collaborative approach for design and prototype development, including the functional mapping of strategic decisions to capabilities.
- Leveraging our proven project accelerators while aligning with a client’s methodology and IT standards and templates to reduce ramp-up time.
- Configuring robust architecture and execution that includes validation, training, and change management plans wherever necessary.
These proven approaches deliver mission-specific benefits, including:
- Access to and governance of data types including extraction, transformation and aggregation via a scalable platform that supports future growth and expansion.
- Interactive graphs and statistical modeling with seamless integration of analytical best practices and existing analytic and predictive programs.
- Harmonized metric-related businesses data models and tools to promote a unified view of Quality across your organization and its external partners / CMOs.
- Reduction in manual and redundant process steps, human error, and long-term costs of the program.
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