Optimizing Product Realization

input
  • Customer Requirements
  • Regulatory Requirements
  • Business and Financial Objectives
Output
  • Increased Customer Satisfaction
  • Regulatory Compliance
  • Increased Shareholder Value

EngiSystems takes an integrated approach to driving end-to-end quality and business performance. We break down silos and optimize product realization to better manage total risk.

OUR SERVICES

  • Quality Systems Performance: A Competitive Advantage

    We help clients enhance quality performance that meets expectations of customers and regulators, while achieving a competitive edge and increasing shareholder value.

     

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  • Optimizing Manufacturing

    EngiSystems partners with you to create efficient production processes with the appropriate controls to improve quality and reduce cost.

     

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  • Information Technology: The Digital Evolution

    Meet the demands for quality and business performance with a data-centric approach to quality and business processes.

     

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  • Streamlining Product Development Lifecycle

    Our experts work with you to shorten development timelines while anticipating and addressing regulatory requirements.

     

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  • Increasing Business Performance

    Avoid significant losses caused by non-routine quality events by establishing a high performing quality management system.

     

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Our Solutions

  • Quality & Business Performance

    Quality & Business Performance

    Our unique approach of “Optimizing Product Realization” recognizes the co-dependencies between Quality and Business Performance. At EngiSystems, we take a strategic perspective that recognizes the end-to-end value chain must be properly aligned to deliver on customer and shareholder expectations. Quality cannot be separated from the final product, it must continually be considered in all enterprise activities.

  • Supplier Management

    Supplier Management

    The solutions provided by EngiSystems enable manufacturers to create an efficient and effective feedback process with suppliers to manage quality better. Manufacturing firms that implemented supplier quality management solutions reported an average success rate of 94% for New Product Introductions (NPI) vs. 70% success for those companies that have not deployed such solutions, according to a LNS Research’s 2013 Quality Management Survey.

  • Manufacturing

    Manufacturing

    Manufacturing medical products requires efficient production controls to ensure all processes contribute to the safety and quality of products. A validated production process enables Life Sciences firms to track and follow necessary regulatory requirements. We assist clients in process optimization, validation, engineering and compliance to ensure all manufacturing processes and procedures are within relevant standards. Our compliance, engineering and validation experts help clients safely and cost-effectively bring new products to market.

  • Regulatory

    Regulatory

    EngiSystems believes the only way to ensure compliance is through an integrated, end-to-end approach to quality. Rather than trying to establish compliance within each subsystem, it is more effective and sustainable to horizontally incorporate requirements and establish relationships between subsystems, departments and business units.

  • Quality Systems

    Quality Systems

    The main reason for bringing a new product to market is to improve patient health outcomes. Ensuring Quality Management System architecture is tuned to an optimum level is the foundation for delivering a safe, high-quality product to produce positive patient outcomes and improve business performance. Regulatory bodies require Life Sciences companies to establish and maintain policies and procedures through the entire product realization process. EngiSystems provides value added services to assist Life Sciences companies in all aspects of the Quality Management System for compliance, optimization and knowledge transfer.

  • Information Technology

    Information Technology

    In the Life Sciences Industry, Information Technology plays a significant role in supporting the processes across the organization in all aspects from Quality Systems, Product Development, Supplier Management, and Manufacturing. Utilization of technology provides the automated tools to improve processes and controls to manage complex products.

  • Product Development

    Product Development

    Success in product development relies on continual process improvements, highly efficient procedures, maximum information sharing, and well-organized product development processes. EngiSystems compliance and engineering professionals alleviate the burden of Regulatory and Quality Assurance from clients to minimize spending valuable time away from their business-critical objectives. Our Subject Matter Experts work with clients to remove inefficiencies from product development processes, while ensuring all processes comply with regulatory requirements and guidelines.

THE ENGISYSTEMS™ DIFFERENCE

Regulatory compliance and engineering are part of doing business in the Life Sciences industry. For proper compliance with regulatory guidelines controlling costs, professionals with compliance expertise and knowledge are essential to a Life Sciences company’s team.

METHOD OF EXECUTIONAUDIT DEFENSE PLEDGE

Going through a 483, Warning Letter or Consent Decree Remediation?

WE CAN HELP.

 

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