Xybion Corporation software

Xybion’s eQCM™ is a comprehensive quality management software solution that enables integrated CAPA Management.  eQCM™ provides a comprehensive corrective and preventive actions workflow as part of its enterprise quality management solution. The CAPA solution is integrated to all other core quality management processes. Corrective Action and Preventive Action (CAPA management ) 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.

In today’s regulatory environment, change management is an essential requirement. Organizations must have the ability to maintain their systems and monitor changes to ensure sustained compliance. Common approaches to address these challenges sometimes includes file polling. This is very inefficient and can often miss certain changes if timestamps and other attributes are not modified. ComplianceBuilder is a unique application that monitors any file-based system for changes including additions, deletions, and file modifications. Upon detecting a file change, ComplianceBuilder stores the file version in a unique, secure data repository for ready retrieval.

Labwise XD: LIMS on the Cloud. Drive Process Compliance and Data Integrity. Laboratories performing Scientific Research and Development, Clinical and Preclinical study sample testing, analytical methods development, chemical development can benefit from the out-of-the-box configuration(s) designed to manage the typical material, process, and equipment flows for these teams. Labwise XD can be used to manage GMP and non-GMP-compliant process flows. You can track equipment and control related activities such as calibration and preventative maintenance, allowing you to reduce operational risk and increase compliance. Features for automated reporting allow you to quickly track nonconformances, such as out-of-specification, by the unit operation.

We Have a Passion for Automation: On average, a QC lab has over one thousand data elements that need to be captured and analyzed to test a product. Unfortunately, most lab process steps are executed manually. In these environments, data creation and management are disjointed. This creates data integrity risks and downstream problems. Labwise XD solves these problems. As a modular, integrated, end-to-end business process management (BPM) platform, Labwise XD supports laboratory workflows, such as material flows, equipment management, deviation management, and more.

Managing an R&D laboratory requires an integrated, all-inclusive business process management (BPM) platform to support all workflows. That is why laboratories performing scientific research and development, clinical and preclinical study sample testing, analytical methods development and chemical development turn to Xybion.

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 is a low-code software that helps businesses operating in regulated industries manage compliance, risk, and quality. The powerful cloud-based software facilities 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.