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The regulatory landscape is dynamic in nature, evolving and changing at an accelerated pace. Hence, keeping up with the changing regulations can be an uphill task for organizations in highly regulated industries. Unraveling the complexity of regulatory compliance in the life sciences industry, EngiLifeSciences is helping enterprises bring high-quality, compliant products to the market with their cutting-edge compliance and managed consulting solutions. In an interview with CIO Applications, Gregory Pierce, CEO of EngiLifeSciences, speaks about the regulatory challenges in the life sciences ecosystem and how EngiLifeSciences helps enterprises efficiently combat them with their innovative services.
Could you share an overview of EngiLifeSciences and the value it brings to its clients?
EngiLifeSciences is a consulting firm and provides consultation services to the medical device, pharmaceutical, and biotechnology industry. The company’s consulting expertise encompasses software compliance, software technology, computer system validation, quality systems, and quality and business performance characteristics. We offer an array of services that are targeted at increasing the bottom line of an organization. In the quality systems area, we help with process improvement including compliance. Addressing the regulatory concerns and issues, we assist our clients in transforming their processes to a compliant state and also help in remediation of various areas of the quality systems.
When it comes to quality and business performance, EngiLifeSciences focuses on product development, manufacturing, information technology, quality systems, and how these processes can integrate together to offer end-to-end visibility, helping organizations identify opportunities. This visibility enables organizations to pinpoint their internal challenges and confront them immediately instead of dealing with them later unprepared.
One of the visions of EngiLifeSciences is to be a transformational agent in the life sciences industry, bringing more innovative approaches to organizations and impacting their internal processes so that they are more adaptable to the external changes occurring in the industry. We help organizations keep pace with the rapidly changing regulatory ecosystem and become more agile so that they can attune faster to the external conditions in the market.
What are the challenges that organizations encounter in the Life Sciences arena in terms of regulatory compliance? How is your company helping in overcoming the challenges?
For compliance challenges and regulatory changes that occur in the life sciences industry, EngiLifeSciences has devised MEV GridTM that stands for maturity, efficiency, and visibility. The grid embeds end-to-end visibility, maturing processes, and efficiency within the processes and technologies in an organization. We have also come up with a 3PO ModelTM that can help our clients identify opportunities, which can impact the bottom line within the first year we do the assessment. EngiLifeSciences 3PO Model helps in driving operational efficiency so that when industry changes occur, there is a lower implementation cost and higher efficiency and execution.
One of the visions of EngiLifeSciences is to be a transformational agent in the life sciences industry, bringing more innovative approaches to organizations and impacting their internal processes
Could you elaborate the process that you follow to onboard a client, all the way from understanding their requirements to developing their product roadmap?
We begin with an assessment process, and a part of the process is helping clients understand their strategic objectives. Following that, we conduct tailored studies at different levels in an organization, all the way from management, performance management area, to the training of company personnel. We also assess the vitality of the organization’s structure and the supporting business requirements and analyze these studies to help CEOs identify opportunities that they are not aware of, which often times act as an eye-opener to them. Today, CEOs in the diverse industries are challenged with the lack of end-to-end visibility, and they often strive to enhance operational efficiency while increasing agility. These studies help discern the gaps that may lie within the organization and meet the aforementioned objectives. We also aid organizations in determining if they are incognizant of any internal regulatory compliance risks.
Please shed some light on EngiLifeSciences’ Computer System Validation (CSV) and Global Validation Governance solutions.
For the CSV element, we write systems validation. As we are moving toward a digital world, it is becoming imperative for systems utilized in an organization to be validated for their intended use. One of the services we provide is global validation governance whereby EngiLifeSciences adopts a centralized approach to set up one process instead of 50 different processes across all the business units to perform computerized systems validation. The biggest benefit of the centralized approach is that organizations can have one central process to validate all their software systems, which need not be altered for every project, thereby saving significant time.
Could you elaborate on the centralized approach?
The centralized approach also increases communication and one receives feedback loops to improve the processes. We have done optimization assessments for some of the largest medical device organizations and have concluded that processes that are not standardized or can’t replicate quickly amount to significant overheads. The five elements that we consider to streamline the computerized systems validation process itself is lifecycle framework, process scalability, risk-based approach, process standardization, and then removing the non-value-added aspects in the process. Another service that we provide the computerized system validation is a part of our managed solution wherein a partner company outsources the task to us. We perform the computers system validation for them and help them maintain compliance so that they can focus on their core business. Additionally, we are putting together a digital solution, leveraging which we can provide a service that can help companies maintain their documentation in a completely data-centric way for validation activities on an ongoing basis.
Could you share a customer success story to substantiate the efficacy of your solutions?
EngiLifeSciences had undertaken an optimization project for one of the largest medical device manufacturers, a global enterprise that was looking to reduce the overhead in their computerized system validation process. We collaborated with the organization, interviewed 27 teams across the organization and helped them streamline and standardize some of their processes. Within a small window of time, EngiLifeSciences was able to reduce the client’s overall operational cost by 20-30 percent, the identified saving being more than 25 percent.
How does the future roadmap look like for EngiLifeSciences?
Moving ahead, EngiLifeSciences is focusing on the process areas of the quality systems to introduce automated solutions that are more integrated. We are also looking to accelerating and increasing visibility within organizations with the 3PO Model to help identify opportunities and positively impact the bottom line. We are aiming to implement technology to improve the visibility so that executives and CEOs have a clear understanding of their internal processes and help their organizations become more agile and adaptable to external changes that occur.