eQCM XD

Xybion’s eQCM® XD is a highly-adaptable and technologically-advanced Governance, Risk, Compliance (GRC) & Quality Management System (QMS) designed for today’s digital world. Purpose-built with embedded quality and compliance, this next generation enterprise risk management software platform ensures compliance, risk and quality in complex and highly-regulated industries.

Xybion’s validated QMS software provides powerful cloud-based capabilities that facilitate 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, Xybion’s Digital Quality Management System automates compliance, risk & quality management while ensuring that companies maintain a seamless workflow connecting internal organizations with external partners, vendors, and regulators in highly-regulated work environments.

eQCM XD Modules

CAPA MANAGEMENT

AUDIT MANAGEMENT

INTERNAL CONTROLS

COMPLAINT MANAGEMENT

CHANGE MANAGEMENT

IT GOVERNANCE

NONCONFORMANCES

INCIDENT MANAGEMENT

DOCUMENT MANAGEMENT

PROGRAMS AND OBJECTIVES

TRAINING AND COMPETENCY MANAGEMENT

QUALITY MANAGEMENT REPORTING

The eQCM XD Difference

eQCM XD is built on the Xybion Digital Acceleration Platform, a new low-code technology stack that powers faster innovation, increased operational efficiency and reduced cost. This Enterprise Risk Management software was designed for industries where high levels of regulations and strict evidence-based  activity documentation are necessary for both compliance and/or safety and liability management. The platform helps global organizations effectively automate, manage, and control compliance and quality process flows such as risk management, Corrective and Preventive Actions (CAPA), deficiency, nonconformance, customer complaints, audit management, training and competency-based learning management, incident management, risk, internal control, and more.

eQCM XD Key Features:

Embedded Enterprise Content Management

  • eQCM XD has a powerful Enterprise Content Management (ECM) system integrated with the process management and workflow engines built into the XD Platform. It has all the features and functions inherent to any best-of-breed content management system. The XD Platform’s query system supports 100% search capability for every word and workflow, while the embedded ECM allows rapid creation of any report based on selected meta data or search words. Built-in analytics allow for rapid creation of customized dashboards that enable you to manage workflows, know where each document is in its lifecycle, and understand who has control over the document at any time. Dealing with an external audit or inspection questions is a simple affair… It allows you to quickly render any document classified by type, department, creator, data content, etc., along with full audit trail.

Embedded Business Process Management

  • As a purpose-built, cloud-based and process-driven enterprise quality and compliance management platform, eQCM XD utilizes a case management functionality that is built on top of a robust Business Process Management (BPM) engine and other integrated document and quality, compliance, risk and governance capabilities. eQCM XD is designed to facilitate detailed and consistent BPM for regulated industries and commercial enterprises.
  • The platform incorporates adaptable BPM capabilities and out-of-the-box compliance, quality, risk and governance features that allow organizations to manage various data collection, cases, issues, actions, follow-up, complaints, audits, checklists, events, ethics and compliance, and many other business activities.

Leveraging Proactive Workflows

  • eQCM XD delivers a foundational set of consistent workflow processes that enable proactive management of tasks and activities particularly helpful in Corrective and Preventive Actions in a timely manner. Managers can create and store action plans in a library for reuse, saving valuable time.
  • Additionally, Xybion’s Enterprise Risk Management software has intuitive, powerful configuration options for building workflows, forms and rules in accordance with your business process which helps in monitoring various performance objectives. Pick/select fields, form design, business rules on fields, flow, and notifications are all configurable. The search and reporting capabilities allow the organization to report on the various benchmarking information across their portfolio.
  • eQCM XD is unique in its ability to be quickly configured at module, sub-module, workflow, screen and field levels. The full platform can automate workflows, manage content, and integrate into existing technology environments, as well as granularly control and secure the activities of the different user roles within the system.

Modular – Deploy Only What You Need, When You Need it

  • eQCM XD consists of a suite of modularized components which can be added to a core implementation as the organization’s needs grow and change. Our solution is designed for maximum flexibility and easy adoption to any organization’s unique quality and compliance processes.
  • eQCM XD’s modular platform architecture allows you to deploy ONLY the functionality that you need TODAY yet remain positioned to scale and rapidly ramp up new functions as needed without disrupting existing business operations. eQCM provides “One Platform” and “One Solution” to meet your immediate business demands, and the dexterity to drive each step of your organization’s strategic roadmap.

Enterprise Benefits:

  • Significant reduction in time to final report and study close-out
  • One integrated preclinical platform covering the entire end-to-end preclinical data management process, enabling you to consolidate systems and reduce costs
  • Functionality to support business process as well as study management requirements
  • Built-in features to support regulatory compliance with IACUC, AALAC, GLP, 21 CFR Part 11, and internal training requirements
  • Seamless integration with data sources and equipment across business functions
  • Integrated with Emidence® XD ECM (Enterprise Content Management) and compliance infrastructure
  • Support for testing and validation
  • Reduced IT support costs due to system consolidation and application landscape simplification