Paragon Solutions Launches Quality Analytics Service Aimed at Helping Manufacturers Comply With New FDA and Global Health Authority Requirements
CRANFORD, NEW JERSEY – December 17, 2015 – Paragon Solutions, an advisory consulting and systems integration firm, announced the worldwide release of its Quality Analytics Service, which helps Life Sciences organizations maintain awareness of the current state of manufacturing quality and comply with FDA and regulatory entity requirements.
“Like other health authorities, the United States FDA is pursuing industry standards for quality metrics and the need to collect, integrate and manage manufacturing data has become critical to maintaining a strong compliance position” reports Kevin Lea, Vice President and Client Partner at Paragon Solutions. “Quality analytics measures are increasingly being recognized as key tools for ensuring an uninterrupted supply of medicines and monitoring compliance across industry supply chains.”
For pharmaceutical manufacturers, Quality Operations teams have a critical need to proactively monitor product quality over time, leveraging available data to drive continuous improvement. Analytics are needed to do that, and help identify potential issues and risks before the cost and impact become unacceptable.
Having completed significant work with three of the top 10 pharmaceutical manufacturers, as well as several Tier 2 and Tier 3 life sciences organizations, Paragon is a leader in quality management and compliance process improvement services. The Paragon team is also playing a major role in the development and release of the DIA GMP Quality Systems Reference model, currently under final review by the Drug Information Association.
An Integrated Approach
Paragon takes an integrated approach to Quality Analytics that includes industry best practices, Health Authority priorities, and critical metrics. By identifying and enabling consistent evaluation of these key performance indicators (KPIs), Paragon provides a target state that delivers decision support capabilities, business process design and a robust analytics foundation.
“Paragon develops comprehensive analytics platforms to enhance decision-making with respect to manufacturing quality and field-based information, including corrective actions” says Lea. “Being a leader in quality analytics, monitoring and reporting stands to add significant value to the current supply chain as well as future product line expansions, thereby delivering competitive advantage for any manufacturing organization.”
By combining the advanced capabilities of its Quality Analytics Services with deep expertise in manufacturing and business intelligence, Paragon is able to easily identify opportunities for improvement and harmonize metric-related data models and tools to promote a unified view of Quality across organizations and its external partners/CMOs. More information on Paragon’s Quality Analytic Services can be found on their website at consultparagon.com.
About Paragon Solutions
Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability and regulatory compliance.
Paragon works with businesses that are focused in a few key industries − communications, financial services, healthcare, insurance, and life sciences. The industry-focused practices work with Paragon’s competency groups to address today’s client concerns in Process Optimization, Information Management, Information Governance and Information Integration. For more information, please visit the Paragon website at www.consultparagon.com, or call 1.800.462.5582.