Xybion Life Sciences
Unifying R&D, Regulated Lab Operations, Quality, Risk, Compliance & Safety:
All-In-One Cloud Platform
Xybion Life Sciences
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.
Risk & Compliance
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, Audits, 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.
Our Solutions
Bio-Pharmaceutical Research & Development
Protocol Management
Preclinical & Drug Discovery Solutions
Lab Animal Science
Laboratory & Sponsor Operations Management
Drug Stability & Sample Management
Formulation & Clinical Supply
Instrument, Equipment & Facility Management
Data Warehouse & SEND Submissions
Clinical Trial Management
Audit Readiness, Deviation & CAPA
Learning Management
Predictive Compliance & Quality Management
Validation Service & Validation Automation
Enterprise Content Management
SEND as a Service
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.
Compliance, Quality & Risk
Quality Management System (QMS)
Compliance Prediction & Business Risk Assessment
Quality Audits
Third Party Audit Solution & 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. Core solutions include:
Quality Management
Governance, Risk & Compliance Solutions
Equipment Qualification & System Validation
Records & Information Management
Asset & Maintenance Management
Deviation Tracking & CAPA
QC Lab Automation
Batch Record Review Automation
Data Integrity
GxP Audit
Third Party / Supplier Audit
Xybion’ software solution, CQRM XD, 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. CQRM XD 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 CQRM XD, quality management, Enterprise Asset Management and Enterprise Content Management solutions.
Sales & Marketing
Ethics & Compliance In Sales
Website Content Compliance
Enterprise Content Management
Procurement
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.
