Low-code GRC, QMS, and ECM Platform

Your all-in-one Governance, Risk and Compliance (GRC), Quality Management Software (QMS), and Enterprise Content Management (ECM) platform

Designed for today’s digital world, CQRM XD is a low-code software that helps businesses operating in regulated industries manage compliance, risk, and quality. The powerful cloud-based software facilitates organizational compliance with regulatory guidelines such as:

ISO 9001, ISO 13485, ISO 17025, ISO14001, GxP, 21 CFR Part 11, financial reporting and governance regulations (SOX, CA Bill 198), risk-based regulations, and other industry standards.

Easily tailored to your specific operating style and business needs, our system automates business processes while ensuring that companies maintain a seamless workflow connecting internal departments with external partners, vendors, and regulators.

Reduce IT support costs by consolidating systems in a cloud-based digital environment.

The CQRM XD Quality Management Software Difference

CQRM XD Quality Management software is built on the Xybion Digital Acceleration Platform, a new low-code technology stack that powers faster innovation, increased operational efficiency, and reduced cost. This Enterprise Risk Management software was designed for industries where high levels of regulations and strict evidence-based  activity documentation are necessary for both compliance and/or safety and liability management. The platform helps global organizations effectively automate, manage, and control compliance and quality process flow such as risk management, Corrective and Preventive Actions (CAPA), deficiency, nonconformance, customer complaints, audit management, training, and competency-based learning management, incident management, risk, internal control, and more.

CQRM XD Quality Management Software Key Features:

Embedded Enterprise Content Management

  • CQRM XD Quality Management Software has a powerful Enterprise Content Management (ECM) system integrated with the process management and workflow engines built into the XD Platform. It has all the features and functions inherent to any best-of-breed content management system. The XD Platform’s query system supports 100% search capability for every word and workflow, while the embedded ECM allows the rapid creation of any report based on selected metadata or search words. Built-in analytics allows for rapid creation of customized dashboards that enable you to manage workflows, know where each document is in its lifecycle, and understand who has control over the document at any time. Dealing with an external audit or inspection questions is a simple affair… It allows you to quickly render any document classified by type, department, creator, data content, etc., along with a full audit trail.

Embedded Business Process Management

  • As a purpose-built, cloud-based, and process-driven enterprise quality and compliance management platform, CQRM XD Quality Management Software utilizes a case management functionality that is built on top of a robust Business Process Management (BPM) engine and other integrated document and quality, compliance, risk and governance capabilities. CQRM XD Quality Management is designed to facilitate detailed and consistent BPM for regulated industries and commercial enterprises.
  • The platform incorporates adaptable BPM capabilities and out-of-the-box compliance, quality, risk, and governance features that allow organizations to manage various data collection, cases, issues, actions, follow-up, complaints, audits, checklists, events, ethics and compliance, and many other business activities.

Leveraging Proactive Workflows

  • CQRM XD Quality Management Software (QMS) delivers a foundational set of consistent workflow processes that enable proactive management of tasks and activities particularly helpful in Corrective and Preventive Actions. Managers can create and store action plans in a library for reuse, saving valuable time.
  • Additionally, Xybion’s Enterprise Risk Management software has intuitive, powerful configuration options for building workflows, forms, and rules following your business process which helps in monitoring various performance objectives. Pick/select fields, form design, business rules on fields, flow, and notifications are all configurable. The search and reporting capabilities allow the organization to report on the various benchmarking information across their portfolio.
  • CQRM XD Quality Management is unique in its ability to be quickly configured at module, sub-module, workflow, screen, and field levels. The full platform can automate workflows, manage content, and integrate into existing technology environments, as well as granularly control and secure the activities of the different user roles within the system.

Modular – Deploy Only What You Need, When You Need it

  • CQRM XD Quality Management Software consists of a suite of modularized components that can be added to a core implementation as the organization’s needs grow and change. Our solution is designed for maximum flexibility and easy adoption of any organization’s unique quality and compliance processes.
  • CQRM XD Quality Management’s modular platform architecture allows you to deploy only the functionality that you need today yet remain positioned to scale and rapidly ramp up new functions as needed without disrupting existing business operations. CQRM XD Quality Management provides “One Platform” and “One Solution” to meet your immediate business demands, and the agility to drive each step of your organization’s strategic roadmap.

Enterprise Benefits:

  • Significant reduction in time to final report and study close-out
  • CQRM XD is the only Comprehensive Predictive Compliance & Quality Risk Management Platform that provides an end-to-end Governance, Risk, Quality, and Compliance management system with a proprietary patented AI algorithm that proactively mitigates your risk exposure.
  • Functionality to support business process as well as study management requirements.
  • Built-in features to support regulatory compliance with IACUC, AALAC, GLP, 21 CFR Part 11, and internal training requirements
  • Seamless integration with data sources and equipment across business functions
  • Integrated with Emidence XD, ECM (Enterprise Content Management), and compliance infrastructure
  • Support for testing and validation
  • Reduced IT support costs due to system consolidation and application landscape simplification.

Achieve Total Compliance with CQRM XD Quality Management Software Modules

Ready to learn more? Contact us to Setup a 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 | Head of Operations: India

Priya is responsible for Xybion business growth in APAC region. She brings over two decades 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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