Xybion offers a comprehensive suite of solutions for the Life Sciences sector.  We are helping Life Sciences companies to solve business problems and add new capabilities to make them more productive and innovative. Our company was founded and continues to focus on helping companies operate in compliance with regulatory requirements.  Life Sciences present unique challenges in the scope and volume of regulations both nationally and globally. Our team of experts develops software products and provide services to create unique industry specific solutions.  These solutions include a wide range of functional areas including:

• Preclinical Solutions – software and services that automate and streamline preclinical and drug discovery business
• Digital Lab Management Solution – lab management systems such as LIMS, ELN, lab data management, analytics, and submissions
• Compliance & Risk – comprehensive quality and compliance solution to predict business risk using Xybion FDA 483 database. Our services include CSV, quality management and audits
• Quality Management – software that helps to define and to manage quality systems including policies, SOPs, employee training, Audit, Deviation, and CAPA
• Validation – validation as a service and validation automation
• Asset Management – software and services to help you maintain your vast array of physical assets

We have Partnered with Life Sciences Companies for Over 40 Years

• We work with all of the top 10 global Life Science companies
• Our preclinical software and services are being used by most large Pharmaceutical companies and large CROs
• Many major Medical Device companies are using our products and services globally
• Our solutions being used by the small/start-up organizations using the build-operate-transfer model
• Xybion quality, compliance, and validation services are used by dozens of leading laboratories and Pharmaceutical companies worldwide
• Xybion offers consulting services for Business Analysis, Project Management, Process, and Scientific Operations improvement work
• We have implemented and provided support for IBM Maximo asset management solutions.
• We have compliance plug-in software to enhance Maximo compliance with regulations
• Provide enterprise data migration solutions at several Pharmaceutical and Medical Device companies
• Xybion SEND intelligence service is being used by several large Pharmaceutical and CROs

Life Sciences companies face many unique challenges.  In an age of enhanced consumer awareness and FDA initiatives surrounding pharmaceutical quality, it is critical that companies focus on product quality throughout the product lifecycle to reduce operational and reputational impacts and costly product recalls.  In addition, regulatory, revenue, channel, and competitive pressures make it increasingly important for these companies to foster quality resources for profitable growth.   At Xybion, through our family of solutions, deep domain experience, and work experience of over 40 years, we can help Life Sciences companies solve business problems and create improved business capabilities.

Bio-Pharmaceutical Research & Development 

• Protocol Management
• Preclinical and Drug Discovery Solutions
• Lab Animal Science
• Laboratory and Sponsor Operations Management
• Drug Stability & Sample Management
• Formulation and Clinical Supply
• Instrument, Equipment & Facility Management
• Data Warehouse & CDISC-SEND
• Clinical Trial Management
• Audit Readiness, Deviation, CAPA
• Training & Competency Management
• Predictive Compliance & Quality Management
• Validation Service and Validation Automation
• Enterprise Content Management
• SEND as a Service

Compliance, Quality & Risk

• Quality Management System (QMS)
• Compliance Prediction and Business Risk Assessment
• Quality Audits
• Third Party Audit Solution and Service
• Document Management System (DMS)
• 21 CFR Part 11 Compliance
• Validation Services

Solutions For Manufacturing

Quality improvement and control is the most important business concerns for manufacturers worldwide. The common goal shared by all small, medium, and large manufacturers is to continuously improve the quality, effectiveness, and the profitability of their operations. To compete better and to continue to be preferred supplier to their customers, manufacturers need to follow best practices and conform to applicable regulatory requirements.  Many will also implement quality standards such as ISO to reduce costs, shorten the production cycle and improve overall performance and compliance.

Xybion provides a comprehensive suite of technology and services that are designed to help manufacturers improve performance and reduce costs.  Some of our core solutions are…

• Quality Management
• Governance, Risk and Compliance Solutions
• Equipment Qualification and Systems Validation
• Records and Information Management
• Asset and Maintenance Management
• Deviation Tracking & CAPA
• QC Lab Automation
• Batch Record Review Automation
• Data Integrity
• GxP Audit
• Third-Party/ Supplier Audit

Xybion’ software solution, eQCM^TM, is designed to help run operations efficiently and flawlessly. Automating processes for quality management, document management, risk management, change control, and other complex processes is our expertise. eQCM enables manufacturers to comply with ISO and other industry standards, reduce manual operations and helps them proactively identify and resolve quality issues.

Xybion offers comprehensive industry solutions for manufacturers including eQCM, quality management, Enterprise Asset Management and Enterprise Content Management solutions.

Xybion contract compliance solution automates the following activities. Our solution helps improve the procurement/contract team productivity by up to 70%. A typical SOW may take 30 minutes to review manually, but Xybion’s solution can review and compile the status report in under one minute.

• SOW/MSA/contract review
• Vendor SLA review
• Invoice review and invoice compliance with SOW
• Rate card comparison
• Vendor quality scorecard
• Supplier risk management
• Supplier audits