EngiSystems, Inc.: Helping Healthcare Enterprise Drive Quality and Business Performance Across the Value Chain

Gregory W. Pierce, President
Today, Life Science firms around the world are manufacturing and launching products in a competitive and rapidly changing regulatory landscape. Any minor non-conformances in this heavily regulated industry can result in organizations being besieged with consent decrees, material failures, heavy penalties, and a tarnished brand image. The enforcement directive’s emphasis is on addressing the significant gaps in quality requirements of industry. “The only way to ensure compliance is through an integrated, end-to-end approach for quality management,” says Gregory W. Pierce, President and Founder, EngiSystems. The Mason-based company offers enterprise-class compliance and engineering solutions, which alleviate the burden of regulatory and quality assurance enabling clients to focus on their business-critical goals. The company was instituted with a mission to drive correlation between quality and business performance by implementing key optimization steps required to achieve product realization. In this regard, the company provides sustainable product development solutions for manufacturers to pilot high quality, compliant products into the market. “We partner with a broad range of medical device manufacturers to help them streamline processes, improve efficiencies, and maintain regulatory compliance,” says Pierce.

Changing the Compliance paradigm

According to the data gathered during Food and Drug Administration (FDA) Domestic Inspections 2014, nearly 50 percent of Quality System Surveillance resulted incompliance failures. According to the data, 1600 Quality Systems Surveillance Inspections were performed. Out of these 1600 inspections performed, 750 of the inspections were issued 483s by the FDA. With a goal to alleviate these pitfalls, EngiSystems proffers an integrated approach for quality management across the entire value chain. Towards this, the firm establishes symbiotic relationships between every subsystem, department and business unit to horizontally incorporate the quality requirements. “Rather than trying to establish compliance within each subsystem, our sustainable technique finds co-dependencies between disparate systems and allows us to uphold compliance at every level of product lifecycle,” explains Pierce.

The company promulgates efficient Product Development Lifecycle (PDL) by working with the client through three different phases—develop, design, and validate. In the first stage, the company works with the client to develop a comprehensive process vision, map regulatory processes and requirements, and leverage structured methodologies to shorten the product development timelines. This is followed by a review period where EngiSystems’ professionals transfer knowledge know-how to the client on cost-effective designing. During the verification and validation stage, the company’s senior software validation engineers assess the software development processes to ensure the implementation of best regulatory practices. “Our step-by-step guidance at every stage of the medical devices’ PDL equips clients to develop efficient and bring high-quality products to market,” evinces Pierce.

The Digital Evolution for Life Science Companies

As it transitions to a full digital state, the Life Sciences Industry is challenged by the regulatory requirements for quality management. These requirements can impede organizational perceptions of the difficulties in adopting new systems to support an organization’s business and quality system processes. However, there are approaches to overcome the regulatory challenges in implementing data-centric business processes, even in an increasing regulatory environment across the globe.

One of the key aspects to overcome the increasing regulations and need to reduce costs while innovating and growing is to establish a data-centric approach. The approach must integrate the Quality System and Business Processes across the business. There exists a break down across these business elements which can play a significant role in product realization, merger acquisition, and integrating the business and quality processes to work together efficiently.

Our sustainable techniques find codependency’s between disparate systems and allows us to uphold compliance at every level of product lifecycle.

Unfortunately, many organizations start looking at the validation requirements late in the lifecycle of these projects which can increase costs significantly, impact timelines, and put the program and project at risk. Laying down the required strategies and plans to meet the regulatory requirements early in the lifecycle minimizes risk and reduces the cost of the overall project. Often, the integrators are really good at integrating the systems, however, they fail to recognize and understand the regulatory requirements for Computer Systems Validation into the overall program and plans.

They had a client in consent decree facing remediation of 700+ software systems with regulatory implications. This required the use of a risk prioritization approach, remediate manufacturing equipment and automated systems (e.g. CNC, Robotics, Custom Equipment, Packaging Equipment, inspection systems) and enterprise wide information systems (supporting manufacturing, product development and Quality Systems). The challenge was to quickly adapt to the current state of the company, on board teams to develop a complaint process meeting regulatory requirements, implement, and transfer knowledge (train) to the organization in order for organization to sustain a culture of continuous improvement after remediation effort was completed. They remediated all systems to a compliant state under aggressive timelines to mitigate risk of further penalties imposed by the Regulatory Agency. The company passed vertical & horizontal audits that lead to recertification. The auditors auditing the remediated systems commented: “the [system’s] validation package gets a grade A+”

Information Technology Solutions

Their Information Technology Solutions include a range of capabilities. They provide strategic level professional support and work on developing strategies to move business processes to a complete data-centric mode. We also assist with the tactical aspects of implementing, maintaining, and validating a compliant state of the systems for use within the regulatory landscape.

In addition, EngiSystems provides Compliance and Optimization assessments to identify organizational opportunities to increase efficiency and productivity that directly impacts the bottom line. EngiSystems works with their clients to implement the identified opportunities and realize the ideal outcomes.

Our Vision

With a vision to infuse quality performance and business performance at every stage of the enterprise, EngiSystems has helped many clients ranging from small firms to Fortune 500 enterprises. “Our broad array of success stories is an upshot of our ability to stay abreast of the latest market trends and disruptive technologies.”

Armed with the right capabilities to reinvent the life sciences landscape, EngiSystems endeavors to achieve the holy grail of end-to-end quality and highly compliant systems. “Our curiosity to develop better ways of doing things empowers us to craft high-end processes and methodologies,” says Pierce. Striving towards such disruption, the company relentlessly seeks to bring ‘out-of-box’ concepts to the marketplace. With these game-changing ideas, EngiSystems’ team is set to infuse regulatory compliance and quality performance techniques across the entire product development lines to sustainably and effectively meet tailored needs of organizations. “Matured processes and products is what we aim to bring to our client’s table,” reaffirms Pierce


Mason, OH

Gregory W. Pierce, President

Helping Healthcare enterprise drive quality and business performance across the value chain

Whitepapers of EngiSystems