Marked by continuous innovation and transformation, the life sciences industry today is on a journey to alter the way it manufactures and commercializes products. This is largely due to the economic pressure exerted by consumers and regulators to increase medical product quality and safety. However, the technologies that can address these needs, often find slower adoption within the life sciences companies. The reason being, complex regulatory requirements for validating manufacturing processes and related software used in the production.

As an outcome, many of the medical devices, pharmaceutical, and biotechnology production processes still employ manual systems and operations that are supported by paper. These inefficient production processes without appropriate controls result in poor quality products as well as increased overall production costs. The Mason, OH-based EngiSystems is set to change this scenario. The company assists life sciences manufacturers in process optimization, validation, engineering, and compliance to ensure all manufacturing processes and procedures are performed in adherence to relevant standards. “Our global regulatory compliance, engineering, and validation experts help clients safely and cost-effectively bring new products to market,” says Gregory W. Pierce, President, EngiSystems.

By offering customized manufacturing solutions to clients, EngiSystems help businesses achieve their goals while complying with Food and Drug Administration (FDA) regulations. The company's solutions help clients perform an overall assessment of the manufacturing production process.

Streamlining the Supply Chain Processes

With its primary focus being the medical device industry, EngiSystems has now expanded its scope of operations to include emphasis on assimilating technology into processes. “Over the years, we have amplified tremendously and now focus on driving efficiency across the life sciences manufacturing space. We are keen on driving quality and business performance through a combination of Information Technology (IT), and using this technology to optimize business processes,” explains Pierce. EngiSystems aims to improve the end-to-end supply chain by enhancing quality and optimizing processes. “Streamlining the processes will have a significant impact for the clients,” Pierce adds. Moreover, when an organization faces challenges and is unsure of devising a strategic roadmap, EngiSystems helps them assess the current state, identify compliance risk, and optimize operations for immediate savings and improved performance.

A Risk Based Approach

EngiSystems creates a systematic process to increase efficiency that not only helps in continually reducing costs but also in identifying areas of redundant effort or inaccurate focus.“One of those is a risk based approach focused on reducing the overall effort taken to perform the overall activities, while emphasizing the efforts on higher risk areas,” reckons Pierce.

We work in a polycentric work environment focused on delivering a high level of service, creating an innovative environment and streamlined approaches to introduce cost effective services and solutions

The more effective the product development, the easier it is to detect defects earlier in the lifecycle and improve quality performance and business performance of the product.The company then evaluates the product development for effectiveness, design implementation, followed by introducing innovative technology to automate the process to enhance traceability, visibility, and impact on changes.

EngiSystems’ immense expertise in the life sciences sector is a reflection of the market pulse. The implementations are conducted by teams that have clear understanding and an innovative perspective to solving problems faster. “We have set up a consulting and support structure of senior industry experts in all areas accessible to the employees,” asserts Pierce. He further adds that this is in contrast to organizations today that use the staffing model ineffectively for meeting their business objectives and fail to achieve the desired results over a course of time. “There is a certain amount of effort required to maximize efficiency in an organization. We can help them realize this through our array of services to increase quality and productivity.”

The company also pays keen attention to Process Validation and Automation Validation functionalities. “Automation Validation involves the software validation requirement that is essential from a regulatory perspective,” says Pierce. Besides, companies in the life sciences sector restructure Installation Qualification (IQ) and Operational Qualification (OQ) processes for automated software systems to seamlessly integrate with the process validation process.. EngiSystems helps clients with the compliance, providing them with increased visibility that will make them prepared for every situation.

A Transformative Approach

Understanding the medical devices, pharmaceuticals, and biotechnology trends allows EngiSystems to evaluate and analyze each regulatory line and identify key challenges faced by manufacturers. The company has not only partnered with global clients, but also has worked with Medical Device Innovation Consortium (MDIC), Xavier University, FDA and Industry over the years, collaborating on product quality indicators for pre-production and post-production processes. The firm’s vision is to be transformative and be an agent of change to make improvements in the industry.

In one instance, EngiSystems worked with a client that could not meet the regulatory requirements successfully. The company assessed the client’s compliance requirements and details for software development including medical device software systems, IT Enterprise Systems and manufacturing systems.

In order to address the issue, EngiSystems identified the potential risk areas of the client and reengineered their processes. The firm helped the client create new departments to maintain proper controls and track the performance effectively. This resulted in successful horizontal and vertical compliance audit for the client.

In another setting, EngiSystems assisted a client with assessment of compliance, optimization opportunities, and in determining the total cost of quality of their products.The customer was facing challenges related to the increased number of non-conformances that were caused by component and material failures. The client was also experiencing global supply chain impediments and had to identify factors to improve product quality while reducing overall costs. With EngiSystems’ assistance, the customer identified approximately $1 billion in potential savings and also enhanced the quality performance of key processes.

"We are keen on making a difference for clients by improving product quality performance, increasing efficiency and reducing overall costs"

An Increased Value Proposition

One of the most critical facets of the life science manufacturing arena today is audits. Clients today face immense stress caused by potential or impending audits. Audit findings can often be expensive if not handled effectively. However, it can be managed successfully through subject matter expertise that contributes to the deliverables that support the project. EngiSystems provides Audit Defense Pledge by offering clients extensive support even after the completion of the project. Through Audit Pledge, the company provides clients with appropriate resources and a timely, qualitative response to the audit. “Our Defense Pledge is a value proposition that also impacts the bottom line. We are keen on making a difference for clients by increasing efficiency and reducing overall costs,” says Pierce. The Audit Defense guarantees would stand behind EngiSystems’ work and defend their deliverables to support clients during an audit. This strategy ensures less stress for the clients about possible audits, curtails the time spent on managing audits, and decreases the financial impact of audit findings. The firm’s audit defense also ensures that the client does not face an audit without expert support.

Success is ensured by the fact that EngiSystems works in a polycentric work environment focused on delivering a high level of service, creating an innovative environment and streamlined approaches to introduce cost effective services and solutions. Striving to stay ahead of the competition by prioritizing on customer satisfaction, the company is working on a new series of solutions that will be launched this year.

As the global life science manufacturing space undergoes a transformational shift, companies require experienced internal resources and specialized expertise to support their business objectives. To achieve this goal, EngiSystems would continue to embrace technology to the fullest, to offer adaptable managed consulting services to their customers. “For the days to come, we will not only forge new partnerships but will also persist to work with software vendors to bring together novel solutions to help clients successfully achieve their goals,” says Pierce.