Digital Lab Management System

Data Integrity | Productivity | Efficiency

Labwise XD: LIMS on the Cloud.
Drive Process Compliance and Data Integrity.

Laboratories performing Scientific Research and Development, Clinical and Preclinical study sample testing, analytical methods development, chemical development can benefit from the out-of-the-box configuration(s) designed to manage the typical material, process, and equipment flows for these teams.

Labwise XD can be used to manage GMP and non-GMP-compliant process flows. You can track equipment and control related activities such as calibration and preventative maintenance, allowing you to reduce operational risk and increase compliance. Features for automated reporting allow you to quickly track nonconformances, such as out-of-specification, by the unit operation.

Labwise XD digital lab operations system unifies lab environments and supports end-to-end business process management (BPM) to deliver increased compliance and productivity.

Built on our proprietary Digital Acceleration Platform, XDP, our powerful, flexible BPM tool seamlessly integrates with other enterprise systems, instruments, and equipment, as well as your customer’s systems, to manage laboratory, data, and procedural workflows in a comprehensive end-to-end digital lab solution.

As an end-to-end digital lab operations system, Labwise XD manages every aspect of your laboratory operations – from contracts to submissions:

Business & Sponsor Management

Manages end-to-end contracts, protocols, employees, vendors, products & services.

Laboratory Operation & Execution

Manages formulations, equipment, facilities, master schedule, data capture, methods, reporting & visualization.

Compliance & Quality Management

Manages the training, document management, deviations, CAPAs, non-conformance.

Digital lab management solution with end-to-end processes, integrated systems, single interface with quality, compliance, and training workflows creates a very happy laboratory workplace.

Data Integrity

  • Automates the current manual lab processes by capturing data from the source enhancing data integrity.
  • Voice over technologies to eliminate manual data entry.

Productivity

  • On average, 15 hrs of timesaving per lab personnel per week

Flexibility

  • Preconfigured workflow automation for labs including – Research & Scientific, Gene & Cell research, QC, Preclinical & Clinical and Bio Specimen testing

Lab Data Lake

  • Lab Data Lake to eliminate point to point connections, instead enabling one too many connections at scale with querying ability.

Purpose-built, Unified Laboratory Management solution includes traditional LIMS, ELN, QMS, DMS, data management, and analytics on a single cloud platform.

Within Labwise XD, a configurable business process workflow engine allows you to manage all aspects of your laboratory business operation – from receiving customer orders and samples, to digitizing your laboratory test protocols and executions (supported by digital QMS, DMS, and GRC modules), to linking customer portals to your CRM system and creating final reports and billing back to your customers.

As a lab data management and analysis software, Labwise XD provides full lifecycle support for integrating critical, regulated workflow processes in a typical laboratory environment.

Labwise XD

Labwise XD solves the problem of massive expenditures by providing a robust, cloud-based digital lab environment that:

  • Displaces disparate systems with a single solution.
  • Ensures data integrity and is fully GDPR and 21 CFR Part 11 compliant
  • Includes a data validation package.
  • Streamlines the entire data management process.

The Xybion Labwise XD platform has been recognized as a Top LIMS Solutions Provider.

“Labwise XD displaces and reduces the burden of buying up to five different systems with a single platform that can be configured to existing processes. The investment payback period is typically one year.”
Kamal Biswas
President & COO | Xybion

Solutions for Every Lab

Labwise XD is pre-configured for various lab environments. As a highly flexible platform, Labwise XD can also be configured for your custom laboratory needs. Within your lab environment, Labwise XD enables you to:

  • Capture and manage critical clinical data.
  • Create an integrated lab environment with all the functionalities of traditional LIMS and ELNs.
  • Automate lab processes / digitize protocols.
  • Manage sample specimen submission and receipt.
  • Connect and manage instruments.
  • Manage content, training, and customer portals.
  • Generate and display results digitally on personalized dashboards.
  • Achieve a single, unified, corporate-wide platform in a true digital cloud environment.
End to End Cloud LIMS Solution

Replaces expensive software components that do not communicate with each other.

End to End Cloud LIMS Solution that:

  • Improves Employee Productivity
  • Faster Product to Market
  • Ensures 21 CFR Part 11 Compliance
  • Reduces Quality Risks

Certificate of Analysis

  • Improved efficiency
  • Data Integrity
  • Easy Storage and Retrieval
  • Unifies System
Certificate of Analysis COA Labwise XD

Sample Management

  • Sample tracking
  • Storage, disposal
  • Handling requests and orders
  • Labeling
  • Processing
  • Analysis
  • Reporting
Sample Management
Sample Management process - Labwise XD
Sample Analysis - Labwise XD

CAR-T, Gene and Cell Therapy LIMS

Manage biological samples, manage specialized reagents & third parties to ensure samples are tracked to the right patient.

Quality Control
LIMS

A modern, smart, low-code digital platform that makes labs paperless, standardize processes, improves data integrity.

Diagnostic Labs
LIMS

Keep customer contract process and interaction simple and provide visibility to customers as real-time as possible.

Research and Science LIMS

Manage GMP/Non-GMP Compliant process flows, track equipment & control activities to reduce operational risk & increase compliance.

CAR-T, Gene, Immuno and Cell Therapy Management System

The Labwise XD digital laboratory solution provides a pre-configured LIMS and ELN product for CAR-T, gene, immunotherapy, and cell therapy labs. This module is specifically designed to work on CAR-T therapy and other similar products that require managing biological samples and specialized reagents. The solution integrates seamlessly with third parties to ensure samples are tracked to the right patient.

Digital Quality Control Lab Management System (QC LIMS )

Are your QC lab operations challenged by ever-changing regulatory demands, nonstandard processes, manual operations, lack of confidence in data integrity, or low bandwidth? Xybion can help.

Our Labwise XD solution transforms lab operations with a modern low-code digital platform that automates business processes and reduces data entry issues to help improve quality and reduce nonconformances.

Diagnostics Lab Management System

Xybion offers an end-to-end laboratory information management system (LIMS) specifically designed for diagnostics labs. Our Labwise XD platform offers a diagnostics digital lab management module that is fully customized to meet the needs of diagnostics laboratories. Our low-code, cloud-based platform can track every kind of sample that your lab processes. From accessioning and ID generation to packaging of final reports, our intelligently designed platform manages all lab processes and enables customers to seamlessly track test progress.

Research and Science Laboratory Management System

Managing an R&D laboratory requires an integrated, all-inclusive business process management (BPM) platform to support all workflows. That’s why laboratories performing scientific research and development, clinical and preclinical study sample testing, analytical methods development and chemical development turn to Xybion.

Electronic Lab Notebook

Labwise XD ELN is a software product created by lab scientists for lab scientist. 
Lab experiments today are no longer done in siloed environments. Experiments are designed and executed by several lab personnel in multiple labs at the same time. These labs are at times are not within the same company. The new ways of doing research & development work collaboratively with scientists within the organization and outside needs flexible, intuitive, and simple Electronic Lab Notebook (ELN). Labwise-ELN is very easy to set up, easy to onboard scientists, connect with any external document or data sources quickly. This is a 21CFR Part 11 compliant solution with electronic signature capability which supports the research claims authenticity.

ELN from Xybion

Pharmaceutical Product Development

lab-worker-background

With the Labwise XD formulation management module, you can tailor protocols and study designs. The digital platform allows scientists in product development departments at biopharmaceutical and generic drug companies to perform step-by-step online foundations based on established methods.

Global Research Protocol Registration System

Whether you are a company scientist, license partner, academic researcher, or CROs, today’s drug discovery research and development operation for biopharmaceutical companies require creating, managing, and executing thousands of in vitro and in-vivo screening assays through traditional or high throughput systems involving chemistry, genomics, biomarkers, animals and human subjects.

Stability Study Management System

With Labwise XD, labs can manage stability studies digitally, reducing mistakes that occur with manual paper-based processes. The Labwise XD stability module features quality, compliance, and electronic lab notebook (ELN) functionality that creates a comprehensive solution for assuring compliance with regulatory guidelines globally.

Ready to learn more? Book a free demo.

Heidi Krueger

Head of Quality Assurance

Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.

James Castonguay

Product Technology Lead

James provides leadership to Xybion quality management systems including product design, development and client delivery. James started working with Xybion in 2002 in its Canadian division. He is now managing product delivery from the United States. James has a master’s degree in mathematics and minor in informatics from the University of Sherbrook, Quebec, Canada.

Dave Chiaramonte

Enterprise Assets and HSE Leader
Dave brings diverse and deep expertise to his leadership role as the leader of Enterprise Asset Management (EAM) and Employee Health & Safety line of business. Dave has over twenty years of experience within the Information Technology industry including development, implementation and integration of complex Enterprise Systems in large corporate environments. He is a highly regarded technology leader in IBM’s Maximo Asset Management Product implementation. Dave worked with BMS and Dupont pharmaceuticals before joining Xybion in 2004.

Tom Klapmuts

Digital Lab Solution Leader

Tom provides leadership in design, delivery and revenue growth of Xybion digital lab solutions. He is an experienced client solutions manager with a demonstrated history of working with many clients globally to solve their business problems. Tom has training in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Life Sciences, CRO Management, and Clinical Development. Before joining Xybion, Tom worked for pharmaceutical companies such as Merck and Schering Plough. Tom is a Purdue university alumnus.

Priya Rajesh

Head of Sales: APAC & EMEA

Priya is responsible for Xybion business growth in APAC and EMEA region. She brings over 18 years of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.

Raji Bijur

Head of Quality Control & CSV

Raji leads Xybion Quality Control function. She has over 22 years of experience in software quality management, CSV, SQA, software process & KPI development and industry benchmarking. She has strong process implementation knowledge including ISO, CMMI, Agile, Scrum, Six Sigma, Lean. Certified CSQA, CSV, GCP, and GAMP. Raji has led implementation of QC processes in Robotic Process Automation (RPA) projects. Before coming to Xybion in 2019, she worked with IQVIA (Former Quintiles), Infosys, Aris Global, Mphasis and serving clients across different market segments. Raji has a bachelor’s degree in information science & technology and MBA from Indian Institute of Management, Ahmedabad.

Bob Friedman

Chief Solution Architect

Bob Friedman has over 25 years of experience in Preclinical information systems at Xybion Corporation as a developer, development manager and Chief Solution Architect. He has been an active member of the CDISC SEND standards consortium for five years as well as the PhUSE / FDA Industry Collaboration. Bob has previously worked for Synthes Orthopedics, NYU Medical Center and the New York State Department of Health. He has a master’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

Gokul Panda

Head of Platform and Product Development

Gokul is the Head of Platform and Product Development, responsible for developing new and critical platforms and products. He has over 20 years of enterprise software development in the life sciences industry and related fields. Gokul holds both a Bachelor’s Degree and Master’s Degree in Engineering from the Indian Institute of Engineering, Science, and Technology. Gokul’s unrivaled expertise in enterprise software architecture and solutions provides Xybion’s clients with leading product functionality, innovation, and platform stability.

Anu Roy

Chief Solutions Delivery Officer

Anu manages project delivery and relationship. She has over 18 years of Life Sciences industry and IT services experience. Anu has a strong track record of designing and developing digital solutions, management consulting, quality & compliance Management, CLM, process & key metrics design, program execution & improvement and account management. Anu is a recipient of the STEM WOC ‘Technology Rising Star ‘by US Women’s magazine in 2014. She has received several other awards including Infosys Consulting Architect Award for outstanding achievement in 2011, RCL Crown Golden Brain Award in 2013. Anu is a guest columnist at Pharmaceutical Compliance Monitor and published in several international business magazines. Anu has a bachelor’s degree in Biochemistry and MBA in marketing.

Keith Dempsey

Chief Information Officer

Keith Dempsey has joined Xybion as our global CIO. He brings 20+ years of progressive Information Technology experience from Merck, AIG, Barclays and PriceWaterhouse. Focusing his career on building global strategies that capitalize on progressive technologies that scale in accordance to realized business growth. His experiences range from introducing new technologies that facilitated a competitive advantage for Merck, introduced new and scalable technologies for AIG Investments, and created progressive global organizational improvements for Barclay’s Capital. Keith has a degree in Chemical Engineering from Clarkson University and an MBA from William Paterson University.

Steve Porfano

Executive Vice President & Chief Financial Officer

Steve manages Xybion corporate function which includes Finance, HR, Legal and QA. Steve joined Xybion in 1989 as Corporate Controller and was promoted to Chief Financial Officer in 1991. As Chief Financial Officer, Steve is responsible for the establishment, enhancement, coordination and administration of the Company’s financial systems, internal controls, and related areas. Additionally, he is the corporate liaison to the Company’s bank, independent certified public accounting firm and governmental compliance and financial auditors.

Kamal Biswas

President & Chief Operating Officer

Kamal joined Xybion as its President and Chief Operating Officer in 2018. He is an acknowledged leader in the life sciences industry and has over 20 years’ experience in management consulting and pharmaceutical business. Very recently, Kamal was a Partner and leader of the global Life Sciences practice at Infosys Consulting. Before that, he spent several years working with pharma companies including Novartis Pharma and Ciba Geigy to manage manufacturing and late-stage R&D functions.

Pradip K. Banerjee, Ph.D., MBA

Chairman of the Board & Chief Executive Officer

Dr. Banerjee is an entrepreneurial senior executive with 30+ years of in-depth experience in the global Life Sciences, Healthcare and Services industry in global operations, strategic management, business development, investments and new ventures creation, M&A and Buy-outs. Prior to acquiring Xybion in 2008, Pradip served as President and CEO of Science Center in Philadelphia focused on creating, incubating, managing and investing in science based new companies. He was the Partner-in-Charge of the pharmaceutical Research & Development unit of Accenture where he created the R&D consulting unit and had grown it to become $100+ million worldwide business. Dr. Banerjee holds a Ph.D. in Pharmaceutical Sciences from University of Wisconsin-Madison and an MBA from the Wharton Business School of University of Pennsylvania.

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