Audit Management Software

Xybion provides a complete audit management software module as part of CQRM XD. Effectively managing audits is essential to any quality management program. Good audit management helps to proactively ensure quality by measuring and improving processes, procedures, and marketed services and products. In addition, supplied products and services can be audited to ensure quality adherence throughout the entire value chain. Early detection and prevention through audit activities is the key to lowering product defects, thereby resulting in higher customer satisfaction.

Audit Management

CAPA Management

Xybion’s CQRM XD is a comprehensive quality management software solution that enables integrated CAPA management. CQRM XD provides a comprehensive Corrective and Preventive Actions workflow as part of its enterprise quality management solution. The CAPA solution is integrated into all other core quality management processes. Corrective and Preventive Action (CAPA) is one of the most daunting tasks of any quality-minded organization. FDA, ISO, EMEA, and other regulations and standards mandate a systematic approach to managing Corrective and Preventive Actions.

Change Management

Effective change management is essential to achieve regulatory compliance and good corporate governance. Our CQRM XD Change Control software modules empower organizations to consistently follow best practices to initiate a change request, follow a risk-based approach to assess the change impacts, create action plans, obtain the appropriate approvals and sign-offs, and provide communication and collaboration throughout all stages of the change cycle. With the Processes-In-Control dashboard, the managers can see the status of current processes, identify bottlenecks, and review critical indicators to optimize process performance

Change Management

Complaint Management

Xybion provides a complete Complaint Management module as part of our CQRM XD Quality Management suite. Customer complaints present unique challenges to manufacturers across multiple industry sectors. By nature, customer complaints represent dissatisfaction with either product quality or performance in a post-distribution environment. Valid complaints may lead to required changes in manufacturing product specifications or the costlier action of a product recall.

Document Management

ECM-XD, based on Xybion’s Digital Acceleration Platform (XDP), provides a single, secure cloud platform architected to integrate end-to-end enterprise processes and content. In addition, the process rules, security, faceted search capability, powerful query builder, and report capabilities allow data to be retrieved at the right time by the appropriate people, which can include partners, external service providers, and other stakeholders via secured solution and mobile platforms.  It offers full versioning, a flexible folder/file structure; workflow-based document review, approvals, and distributions; full-text searches and notifications, and multiple views (structures) of the files in the ECM structure; metadata to tag and perform auto-filling and document workflows.

Incident Management

Xybion’s CQRM XD is an enterprise-class quality management software platform that provides a complete Incident Management solution out-of-the-box. The management of risk is at the heart of incident management. Incident management transcends the mere ability to respond. Effective incident management software requires enterprise collaboration and communication to minimize risk and ensure sustained compliance.

Internal Controls

Xybion provides a complete internal controls and internal audit software solution built inside of the CQRM XD Quality Management suite. The primary responsibility for the development and maintenance of internal control rests with an organization’s management. With increased significance placed on the control environment, the focus of internal control has changed from policies and procedures to an overriding philosophy and operating style within the organization. Emphasis on these intangible aspects highlights the importance of top management’s involvement in the internal control system. If internal control is not a priority for management, then it will not be one for people within the organization either.

IT Governance

Xybion provides a complete IT Governance software solution as part of its CQRM XD Quality Management software suite. In today’s challenging technology and business environment, many compliance processes are driven or highly influenced by IT systems. Such systems, whether QMS, ERP, or otherwise, are integral to initiating, recording, approving, and reporting crucial compliance information in accordance with internal and external mandates. The Sarbanes Oxley Act (SOX), mandates that an internal control framework over financial reporting is established and monitored.

Nonconformances

Xybion provides a complete nonconformance software module as part of its CQRM XD Quality Management software solution. Global regulatory requirements include mandates to deal with products or raw materials that do not conform to product quality requirements. Nonconforming products or materials could lead to costly rework and even product recall. These nonconformities increase the organization’s risk of adverse impacts to business continuity, customer relations, market reputation, or other areas. Manufacturers across multiple industries must comply with guidelines such as cGMP, 21 CFR Part 820, ISO 9001, ISO 13485, and ISO 14001 which all include requirements for the management of nonconformances.

Programs and Objectives

Xybion provides a complete Programs & Management Objectives module as part of its CQRM XD quality management software suite. Historically most organizations viewed the creation and monitoring of management programs as a necessary task to achieve ISO certification. The emergence of governance regulations and the move toward continuous improvement through the monitoring of key performance indicators necessitates that companies look for ways to measure their critical processes against the company goals and objectives to look for improvement and latent risk areas. Thus, companies are setting measurable objectives, recording data to measure against those objectives, and reporting on the status of their compliance as part of their tactical and strategic activities.

Quality Management Reporting

Xybion’s CQRM XD Quality Management software platform provides for a comprehensive quality management reporting and analytics solution. One of the major challenges facing highly regulated companies today is developing a single, consistent, and complete view of compliance-related information across all applications, databases, and enterprise systems.

Learning Management

Xybion provides a comprehensive Learning Management software module as part of its CQRM XD Quality Management software suite. Following cGxP regulations, ISO standards, and OSHA regulations, organizations must ensure that personnel performing various duties have the appropriate education, training, and experience to perform those duties. To document and demonstrate that the requirements are being met, those organizations must also keep training records.

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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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