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 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.

  • 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.

  • 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.

  • 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, and Manufacturing. Utilization of technology provides the automated tools to improve processes and controls to manage complex products. Computer System Validation (CSV) is a time consuming process. Many Life Sciences companies struggle with the requirements of Computer Systems Validation and the effort required to deploy new technologies. At EngiSystems, we provide clients with validation solutions that enable internal resources to work on business objectives while meeting the regulatory standards. Our comprehensive Computer Systems Validation (CSV) services are available for all stages of a computerized system’s life cycle.

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.

 

800.254.7615 CONTACT US