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 provides services to create unique industry-specific solutions. These solutions include a wide range of functional areas including:
Software and services that automate and streamline preclinical and drug discovery business.
Lab Management Systems such as LIMS, ELN, Lab Data Management, Analytics, and submissions.
Comprehensive Quality and Compliance Solution to predict business risk using Xybion FDA 483 database. Our services include CSV, Quality Management, and Audits.
Software that helps to define and to manage quality systems including policies, SOPs, Employee training, Audits, Deviation, and CAPA.
Life Sciences companies face many unique challenges. In an age of enhanced consumer awareness and FDA initiatives surrounding pharmaceutical quality, 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.
Quality improvement and control are 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 profitability of their operations. To compete better and to continue to be a 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:
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.
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.
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.