Quality Manufacturing & Compliance Management - Paragon

Paragon’s solutions empower Quality, Manufacturing and Compliance teams to realize competitive advantages throughout the value chain while minimizing exposure to risk.  Our approach enables manufacturing facilities to produce life enhancing products in a more efficient manner, with higher safety standards, and reduced costs and time to market.

Quality Operations

  •   Overview   

    Operational efficiency is the cornerstone to effectively administering your quality management processes. It increases your company’s ability to deliver both compliant and safe products, mitigate risk, and provide preventive and predictive decision making.

    Our experience and capabilities in Quality Operations address everything from Strategy and Program Builds, to Analytical Insights, through Technology Implementations.

    Quality Operations Framework

    Quality Operations Framework

  •   GxP Content Services   

    The exponential growth of content within the Quality, Manufacturing & Compliance domain, along with ever increasing regulatory pressures, has pushed the management of quality content to the head of the agenda for regulated business priorities.

    Paragon's GxP Content Services can improve how your firm manages this documentation by putting in place best-practice business processes (such as DIA standards) and leading, next-gen technologies for managing regulated life sciences content.  We bring together deep domain expertise in Life Science Quality, Manufacturing and Compliance business processes and information management technology solutions to deliver the following benefits:

    • Reduced compliance risk by providing greater employee accessibility to documents from a single source designed specifically for regulated, quality documents
    • Improved ability to address regulations and guidance from health authorities and reduced risk of audit findings
    • Greater productivity through optimization of business processes
    • Increased collaboration via tighter interoperability with outsourced partners such as contract manufacturing and research organizations (CMOs, CROs) and labs
    • Higher user adoption associated with a modern solution that is user-friendly and requires less training
    • Reduced IT costs by moving to a single, supported solution that is less costly to maintain than older, heavily customized systems

    Data Sheet:  GxP Content Services
    VIEW THE DATA SHEET

  •   Quality Management Systems   

    An effective Quality Management System (QMS) should be the precursor of product research and development.  While the pursuit of a QMS can be daunting on a financial statement, failure to implement an effective QMS can be many times more costly with product failure or recall.

    Based on the latest guidance from the FDA, an effective QMS should maintain the following minimum characteristics to insure compliance with cGMP:

    • Quality Management
    • Quality Assurance
    • Risk Management
    • Preventive Action
    • Continuous Improvements

    Paragon’s Quality SME’s have deep industry experience and can guide your team through a current state diagnosis to determine the maturity level of your overall quality management program. We will then assist you in determining the best approach for you company to deploy a strategy and technology to maintain compliance and mitigate both short-term and long-term risk.

  •   Quality Insights   

    The need to collect, integrate and manage manufacturing data is paramount to maintaining a strong compliance posture. Paragon leverages deep expertise in manufacturing, business intelligence, analytics and knowledge management to help our Life Science clients maintain organizational awareness into the current state of manufacturing quality and 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.

    Quality Analytics

    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.

    Our integrated approach to Quality Analytics 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.   

    We work with your Quality Analytics Group to:

    • Understand and define the Quality target state and opportunities for innovation
    • Prototype key capabilities and processes with real data to gain a full understanding of business requirements
    • Plan and design solution architectures that map to your foundation and growth
    • Analyze business/technical capabilities needed to design the optimal solution that can scale for demand
    • Ensure that quality-critical data is readily accessible, sortable, reportable, and in an interpretable format to respond to regulators
    • Efficiently develop periodic internal and Health Authority product quality reports 
    • Establish processes and systems to proactively monitor product quality
    • Sustainably reduce quality costs and position quality as a competitive advantage
    • Achieve seamless integration of data from disparate sources and systems to enable strategic visualization 
    • Facilitate organizational adoption and capability pull-through via training and change management
    Data Sheet:  Quality Analytics in Life Sciences
    VIEW THE DATA SHEET



    Knowledge Management

    Ideally, knowledge needs to be made explicit to hold value to the user and the organization. More than ever, critical knowledge is about context, pattern recognition, socialization, relationships and the flow of knowledge.

    Paragon’s Quality KM Services include strategy support at all company levels through building business specific knowledge solutions:Quality Knowledge Management
    News Release:  Paragon Solutions Names to KM World's "100 Companies that Matter in Knowledge Management 2017"
    READ THE NEWS RELEASE

  •   Laboratory Information Management   

    Life Sciences companies face significant regulatory constraints within the laboratory landscape―complex batch management, diverse laboratory and testing needs―all of which demand sophisticated enterprise level solution sets.

    Paragon’s Laboratory Information Management capabilities provide labs with business specific options to address key challenges when selecting a LIMS, upgrading platforms or bringing on new labs and technology.

    Paragon's LIMS SMEs deliver industry specific program strategies and execution, product evaluations and selection, and LIMS data services, as well as implementation services to include information architecture, analysis, configuration, validation and migration.  Paragon also provides change management and training programs.

    Benefits include:

    • Compliance with ISO 9000/17025 quality standards
    • Maximize environmental standards
    • Adherence to regulatory standards such as 21 CFR part 11 and GMP requirements
    • Increased lab efficiencies
    • Reduce cost and turn-around time
  • Operational efficiency is the cornerstone to effectively administering your quality management processes. It increases your company’s ability to deliver both compliant and safe products, mitigate risk, and provide preventive and predictive decision making.

    Our experience and capabilities in Quality Operations address everything from Strategy and Program Builds, to Analytical Insights, through Technology Implementations.

    Quality Operations Framework

    Quality Operations Framework

  • The exponential growth of content within the Quality, Manufacturing & Compliance domain, along with ever increasing regulatory pressures, has pushed the management of quality content to the head of the agenda for regulated business priorities.

    Paragon's GxP Content Services can improve how your firm manages this documentation by putting in place best-practice business processes (such as DIA standards) and leading, next-gen technologies for managing regulated life sciences content.  We bring together deep domain expertise in Life Science Quality, Manufacturing and Compliance business processes and information management technology solutions to deliver the following benefits:

    • Reduced compliance risk by providing greater employee accessibility to documents from a single source designed specifically for regulated, quality documents
    • Improved ability to address regulations and guidance from health authorities and reduced risk of audit findings
    • Greater productivity through optimization of business processes
    • Increased collaboration via tighter interoperability with outsourced partners such as contract manufacturing and research organizations (CMOs, CROs) and labs
    • Higher user adoption associated with a modern solution that is user-friendly and requires less training
    • Reduced IT costs by moving to a single, supported solution that is less costly to maintain than older, heavily customized systems

    Data Sheet:  GxP Content Services
    VIEW THE DATA SHEET

  • An effective Quality Management System (QMS) should be the precursor of product research and development.  While the pursuit of a QMS can be daunting on a financial statement, failure to implement an effective QMS can be many times more costly with product failure or recall.

    Based on the latest guidance from the FDA, an effective QMS should maintain the following minimum characteristics to insure compliance with cGMP:

    • Quality Management
    • Quality Assurance
    • Risk Management
    • Preventive Action
    • Continuous Improvements

    Paragon’s Quality SME’s have deep industry experience and can guide your team through a current state diagnosis to determine the maturity level of your overall quality management program. We will then assist you in determining the best approach for you company to deploy a strategy and technology to maintain compliance and mitigate both short-term and long-term risk.

  • The need to collect, integrate and manage manufacturing data is paramount to maintaining a strong compliance posture. Paragon leverages deep expertise in manufacturing, business intelligence, analytics and knowledge management to help our Life Science clients maintain organizational awareness into the current state of manufacturing quality and 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.

    Quality Analytics

    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.

    Our integrated approach to Quality Analytics 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.   

    We work with your Quality Analytics Group to:

    • Understand and define the Quality target state and opportunities for innovation
    • Prototype key capabilities and processes with real data to gain a full understanding of business requirements
    • Plan and design solution architectures that map to your foundation and growth
    • Analyze business/technical capabilities needed to design the optimal solution that can scale for demand
    • Ensure that quality-critical data is readily accessible, sortable, reportable, and in an interpretable format to respond to regulators
    • Efficiently develop periodic internal and Health Authority product quality reports 
    • Establish processes and systems to proactively monitor product quality
    • Sustainably reduce quality costs and position quality as a competitive advantage
    • Achieve seamless integration of data from disparate sources and systems to enable strategic visualization 
    • Facilitate organizational adoption and capability pull-through via training and change management
    Data Sheet:  Quality Analytics in Life Sciences
    VIEW THE DATA SHEET



    Knowledge Management

    Ideally, knowledge needs to be made explicit to hold value to the user and the organization. More than ever, critical knowledge is about context, pattern recognition, socialization, relationships and the flow of knowledge.

    Paragon’s Quality KM Services include strategy support at all company levels through building business specific knowledge solutions:Quality Knowledge Management
    News Release:  Paragon Solutions Names to KM World's "100 Companies that Matter in Knowledge Management 2017"
    READ THE NEWS RELEASE

  • Life Sciences companies face significant regulatory constraints within the laboratory landscape―complex batch management, diverse laboratory and testing needs―all of which demand sophisticated enterprise level solution sets.

    Paragon’s Laboratory Information Management capabilities provide labs with business specific options to address key challenges when selecting a LIMS, upgrading platforms or bringing on new labs and technology.

    Paragon's LIMS SMEs deliver industry specific program strategies and execution, product evaluations and selection, and LIMS data services, as well as implementation services to include information architecture, analysis, configuration, validation and migration.  Paragon also provides change management and training programs.

    Benefits include:

    • Compliance with ISO 9000/17025 quality standards
    • Maximize environmental standards
    • Adherence to regulatory standards such as 21 CFR part 11 and GMP requirements
    • Increased lab efficiencies
    • Reduce cost and turn-around time

Digital Manufacturing

  •   Overview   

    Paragon’s Digital Manufacturing solutions provide our clients with the intelligent assets to improve efficiencies and collaboration on the plant floor and across the manufacturing landscape. As you move through the transformation journey to a connected digital enterprise, our solutions can help you better manage and optimize production, remain compliant, and realize significant cost efficiencies.

    Digital manufacturing capabilities

  •   Information Transformation   

    Effectively managing information is a common challenge for Life Sciences companies, especially in the ever changing regulatory environment of process manufacturing. Our Information Solution offerings help companies achieve intelligent manufacturing by converging operational and informational technologies.

    We help manufacturing operations successfully address information challenges related to:

    • Information Governance
    • Mergers & Acquisitions
    • Systems Integrations
    • MES Application Support
    • Analyze and rationalize applications
    • Resource Utilization & Management
    • Data Integrity
    • Predictive Modeling
    • Information Optimization
    • ERP Archiving
    • System Migrations
  •   Knowledge Management Innovation   

    Our Quality & Manufacturing Knowledge Management services provide the effective models, technology, and process optimization practices needed for your organization to innovate, collaborate, and speed time to market. We help transform teams by delivering strategies, technologies and behaviors to manage knowledge more effectively to meet critical business objectives. We also deploy secure and validated environments that allow for the sharing of content with external partners including CMOs, CROs, Distributors and API partners.

    Paragon’s Knowledge Management experts can help you establish a methodical approach to improving management of critical knowledge that will enable you to:

    • Enhance innovation, business efficiency, knowledge capture and findability
    • Create an environment for sharing confidential regulated information
    • Enhance collaboration between a Contract Manufacturing organization and Contract Quality control lab
    • Enable knowledge sharing support across R&D to Manufacturing and R&D to Quality
    • Improve access to explicit and tacit knowledge between commercial quality and manufacturing teams
    • Eliminate knowledge sprawl and lack of structure
    • Provide taxonomy/ontology management and application for greater knowledge usability
    • Increase efficiency and optimization for faster speed-to-market, greater compliance and innovation

    Case Study:  Communities of Practice for Problem Solving
    VIEW THE CASE STUDY

    News Release:  Paragon Named to KM World's "100 Companies that Matter in Knowledge Management 2017"
    READ THE NEWS RELEASE

  • Paragon’s Digital Manufacturing solutions provide our clients with the intelligent assets to improve efficiencies and collaboration on the plant floor and across the manufacturing landscape. As you move through the transformation journey to a connected digital enterprise, our solutions can help you better manage and optimize production, remain compliant, and realize significant cost efficiencies.

    Digital manufacturing capabilities

  • Effectively managing information is a common challenge for Life Sciences companies, especially in the ever changing regulatory environment of process manufacturing. Our Information Solution offerings help companies achieve intelligent manufacturing by converging operational and informational technologies.

    We help manufacturing operations successfully address information challenges related to:

    • Information Governance
    • Mergers & Acquisitions
    • Systems Integrations
    • MES Application Support
    • Analyze and rationalize applications
    • Resource Utilization & Management
    • Data Integrity
    • Predictive Modeling
    • Information Optimization
    • ERP Archiving
    • System Migrations
  • Our Quality & Manufacturing Knowledge Management services provide the effective models, technology, and process optimization practices needed for your organization to innovate, collaborate, and speed time to market. We help transform teams by delivering strategies, technologies and behaviors to manage knowledge more effectively to meet critical business objectives. We also deploy secure and validated environments that allow for the sharing of content with external partners including CMOs, CROs, Distributors and API partners.

    Paragon’s Knowledge Management experts can help you establish a methodical approach to improving management of critical knowledge that will enable you to:

    • Enhance innovation, business efficiency, knowledge capture and findability
    • Create an environment for sharing confidential regulated information
    • Enhance collaboration between a Contract Manufacturing organization and Contract Quality control lab
    • Enable knowledge sharing support across R&D to Manufacturing and R&D to Quality
    • Improve access to explicit and tacit knowledge between commercial quality and manufacturing teams
    • Eliminate knowledge sprawl and lack of structure
    • Provide taxonomy/ontology management and application for greater knowledge usability
    • Increase efficiency and optimization for faster speed-to-market, greater compliance and innovation

    Case Study:  Communities of Practice for Problem Solving
    VIEW THE CASE STUDY

    News Release:  Paragon Named to KM World's "100 Companies that Matter in Knowledge Management 2017"
    READ THE NEWS RELEASE