Xybion Corporation

Xybion provides a complete audit management software module as part of eQCM. Effectively managing audits is essential to any quality management program. Good audit management helps to proactively ensure quality by measuring and improving processes, procedures, and marketed services and products. In addition, supplied products and services can be audited to ensure quality adherence throughout the entire value chain. Early detection and prevention through audit activities is the key to lowering product defects, thereby resulting in higher customer satisfaction.

Companies complying with FDA, ISO 9001, ISO 14001, OHSAS 18001, ISO 19011 and other regulatory requirements must perform regular audits to reduce the risk of nonconformances, to improve quality and to ensure compliance. The eQCM Audit™ module will help companies attain sustainable compliance by automating, streamlining, and effectively managing the audit process.

Audit is suitable for management and control of a wide variety of audit processes. The flexibility inherent in the design of eQCM Audit™ enables companies to perform quality audits (system audits, process audits, product audits and supplier audits), environmental audits, security audits (site security, function security and data security), or industrial safety audits. It allows companies to plan and execute audit activities, determine schedule conflicts of auditors, record findings and conduct appropriate follow-up actions, and track trends based on audit results. eQCM Audit utilizes the workflow designer, enabling you to configure audit processes and associated forms.

• Internal Audits
• External Audits
• Supplier Audits
• Equipment and facility inspections
• Health & Safety Audits
• Environmental Audits

The Xybion eQCM™suite delivers a comprehensive platform for GRC and quality management. Our comprehensive solution includes embedded best practices and flexibility for deployment in any systems environment. eQCM™is seamlessly integrated with standard enterprise technologies including Microsoft, Oracle, EMC/Documentum and others to ensure compatibility with most systems environments.

• Enterprise Platform
• On-Premise, SaaS Deployment Options
• Advanced Integrated Technologies
• Flexible Process Control Engine
• Compliant With Current Regulatory Guidelines
• Compatible With OCEG GRC Framework
• Ensures Sustained Compliance and Governance

eQCM is Xybion's Flagship Software application for enterprise Quality and Compliance Management.  eQCM provides a comprehensive CAPA software application 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.

While all organizations hope to avoid the root causes that necessitate corrective actions, reality dictates otherwise. Because defects, deviations, or any other gaps that trigger the need for a CAPA can come from a myriad of sources (documents, training, products, etc.), CAPA management has become the core process of a well-established compliance and quality program.

The eCQM CAPA™ module is an integral part of the eQCM quality management suite. It may be used as a stand-alone module in small organizations or integrated with other processes such as nonconformances, audits, training, complaints and others. The eQCM CAPA™ module allows organizations to create a single configurable workflow to handle the entire lifecycle of the CAPA from the triggers that can auto-launch the corrective action to the final sign-off. If your company prefers, multiple workflows can be developed also – without vendor or IT support.

The Xybion eQCM™suite delivers a comprehensive platform for GRC and quality management. Our comprehensive solution includes embedded best practices and flexibility for deployment in any systems environment. eQCM™is seamlessly integrated with standard enterprise technologies including Microsoft, Oracle, EMC/Documentum and others to ensure compatibility with most systems environments.

• Enterprise Platform
• On-Premise, SaaS Deployment Options
• Advanced Integrated Technologies
• Flexible Process Control Engine
• Compliant With Current Regulatory Guidelines
• Compatible With OCEG GRC Framework
• Ensures Sustained Compliance and Governance

Xybion provides a comprehensive learning management software module as part of its eQCM quality management software suite.  In accordance with cGxP regulations, ISO standards, and OSHA regulations, organizations must ensure that personnel performing various duties have the appropriate education, training, and experience to perform those duties.  In order to document and demonstrate that the requirements are being met, those organizations must also keep training records.  Appropriate training facilitates worker productivity, provides assurance to the company that workers are aligned with corporate practices and procedures, and reduces costly human errors that can result in operational interruptions or even loss of life.  Proactive training plans can also enhance a worker’s perception about the corporation, helping companies with employee retention.

Companies wanting to utilize a best practice approach for their learning management requires must Rensure that the learning management system (LMS) allows for the following:

• Security: Training records can only be accessed by designated users

• Validity: Employee training records can be tracked with a high level of granularity ready for external audits

• Visibility: All training record data can be reported on at any time

• Variety of Training Formats:  Managers can create training content, manage training records from a variety of training types (documents, classroom, online, etc.).

• Skill analysis:  Capability to assess competency levels of users

Moreover, the eQCM LMS module helps you easy compliance with requirements for electronic signature, electronic records and software validation such as 21 CFR Part 11 from the FDA.

The Xybion eQCM™suite delivers a comprehensive platform for GRC and quality management.  Our comprehensive solution includes embedded best practices and flexibility for deployment in any systems environment.  eQCM™is seamlessly integrated with standard enterprise technologies including Microsoft, Oracle, EMC/Documentum and others to ensure compatibility with most systems environments. 

The key benefits of our overall solution are:

• Enterprise Platform

• On-Premise, SaaS Deployment Options

• Advanced Integrated Technologies

• Flexible Process Control Engine

• Compliant With Current Regulatory Guidelines

• Compatible With OCEG GRC Framework

• Ensures Sustained Compliance and Governance

Xybion provides an integrated document management software solution as part of its eQCM Suite.  Enterprise document management control is essential to good governance.  Xybion offers an integrated document management module that delivers robust enterprise document management capabilities to support your quality management program.  Our integrated document management provides the ability to quickly find, share and access all document types from an easy-to-use and secured environment.

The eQCM document management module provides full document control over different types of file formats, keeping a detailed history of all changes. eQCM's document management provides cycle control over the creation, approval, modification and retirement of obsolete versions of documents. Automated workflows ensure that documents are routed through all applicable reviewers and authorized in a controlled manner that complies with all regulated document management requirements, including the collection of electronic signatures for specified workflow actions.   Document tasks are sent to a centralized workload and notifications to the user’s e-mail facilitating the timely completion of critical document activities.

eQCM  facilitates compliance with Good Manufacturing Practices (GMP), FDA regulations, ISO requirements, Sarbanes-Oxley (SOX) and other governing regulations and standards which require that companies manage document versions, control which documents are available to employees, and ensure that appropriate change control procedures are followed when revising documents.

The Xybion eQCM™suite delivers a comprehensive platform for GRC and quality management.  Our comprehensive solution includes embedded best practices and flexibility for deployment in any systems environment.  eQCM™is seamlessly integrated with standard enterprise technologies including Microsoft, Oracle, EMC/Documentum and others to ensure compatibility with most systems environments. 

The key benefits of our overall solution are:

• Enterprise Platform

• On-Premise, SaaS Deployment Options

• Advanced Integrated Technologies

• Flexible Process Control Engine

• Compliant With Current Regulatory Guidelines

• Compatible With OCEG GRC Framework

• Ensures Sustained Compliance and Governance