Xybion: A New Generation of Quality Ingrained And Compliance Embedded, Digital...

Pharma Tech Outlook: Pharma Tech Magazine

Xybion: A New Generation of Quality Ingrained And Compliance Embedded, Digital Acceleration Cloud Platform

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Pradip Banerjee, Chairman and CEO, Xybion Pradip Banerjee, Chairman and CEO
It can be challenging for lab-setups in a highly regulated life sciences industry to embrace cloud-based workflows and enjoy its multi-faceted benefits while being compliant with the local and international regulatory requirements. Traditional Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) systems lack the flexibility to adapt to the constant business changes through frequent upgrades or customizations. Also, on-premise solutions are limited in their capabilities to enable interactions with external stakeholders and systems. To this end, New Jersey-based Xybion brings to the table, their novel, purpose-built cloud-based lab management offering. “We describe our offering as Digital Lab Management Solution as it meets the requirements of the new digital business world,” says Kamal Biswas, president, and COO at Xybion.

Xybion addresses four key challenges that had always hindered labs from going digital and paperless in a holistic and compliant manner. First, the solution helps pharmaceutical labs to ensure data integrity and is fully GDPR and 21 CFR Part 11 compliant, Xybion also provides an entire validation package. Secondly, Xybion solves the problem of massive expenditure. “The digital solutions should be simpler, easy to implement, manage and improve the productivity and efficiency of labs. To meet business and compliance requirements, companies need to buy several systems such as quality management systems, document management system, data management & analytics systems with a LIMS. Our cloud-based lab management solution reduces the burden of buying four or five different systems or displaces several existing systems with one platform and can be configured with their existing process. The investment payback period is mostly one year,” says Biswas. In today’s volatile business scenarios, solutions must be well acclimatized to changes. Xybion’s solution, being low-code and cloud-based, renders a higher degree of flexibility and customizability. Lastly, it streamlines the whole data management process for its clients. Historically, the idea of data centralization via data lakes has been rather alien to labs. Biswas points out, “Our system ensures that lab instruments are connected to the Lab Data Lake.
All instruments in a lab environment have a single data source to run analytics which enables our clients to draw meaningful insights seamlessly from the Data Lake. This also ensures the lab instruments are fully updated with the security patches and do not become the source for the security vulnerabilities.”

Your Process, Your Way—is our motto and our ability to address client-specific problems differentiates us in the market

Xybion’s U.S. Patent Pending Compliance Predictor solution–that leverages internal audit results for predicting business risks and setting up plans for being always “Audit-Ready” is another key differentiator. With almost 50,000 records of 483s, citation documents, internal audit databases, Department of Justice fines and settlements, and a country business risk database, it ensures real-time reporting and empowers its clients in the life sciences space to mitigate business risks associated with financial penalties and delayed product launches.

Such unique solutions have enabled Xybion to etch a niche in this space, attaining a number of clients—from large companies to start-ups. In one instance, a large pharmaceutical company lacked a standardized solution to create, review, and manage protocols for internal and external researchers. Engaging with the client, Xybion configured a protocol management system within weeks that is being used by more than several thousands. Protocol standardization became an easy feat. In another instance, a large diagnostics lab had a constant struggle to customize a traditional LIMS to meet their business changes and making their customers happy. Xybion’s digital lab solution made their processes simple, easy to change, and also provided access to their customers for a real-time status update of their work. “Xybion offers Digital Lab Solution on a Build-Operate-Transfer (BOT) model for start-up companies that do not want to make large IT investment,” Biswas added on explaining working models with the start-up or smaller companies.

Motivated by such nonpareil instances of client success, Xybion is pushing its solution to diverse labs—research labs, development labs, quality control labs, diagnostics labs, and more. Striding ahead, the company is looking for reaching different market segments to serve a large clientele. Apart from this, the company plans to expand beyond the U.S. and Canada, with a specific focus on the markets of Europe, India, China, and South Korea. Also, the company is in the process of opening its full-time office in Europe this year. “Our motto—Your Process, Your Way—always drives us to address specific problems of each client, and this differentiates us in the market,” Biswas concludes.
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Princeton, NJ

Pradip Banerjee, Chairman and CEO

Xybion® is a leading cloud based end-to-end Industry software solutions and technology driven services company dedicated to helping corporations solve business problems and accelerate the pace of innovation. We help companies in highly regulated environments to transform into a digital workplace to become more efficient and reduce costs, improve regulatory adherence and be compliance-ready, always, and accelerate the pace of innovation. For more than 40 years, we have helped companies become more efficient, reduce costs and manage compliance, regulatory adherence and risk