Xybion provides a complete audit management software module as part of CQRM XD. 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.
Xybion’s CQRM XD is a comprehensive quality management software solution that enables integrated CAPA management. CQRM XD provides a comprehensive Corrective and Preventive Actions workflow as part of its enterprise quality management solution. The CAPA solution is integrated into all other core quality management processes. Corrective and Preventive Action (CAPA) 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.
Effective change management is essential to achieve regulatory compliance and good corporate governance. Our CQRM XD Change Control software modules empower organizations to consistently follow best practices to initiate a change request, follow a risk-based approach to assess the change impacts, create action plans, obtain the appropriate approvals and sign-offs, and provide communication and collaboration throughout all stages of the change cycle. With the Processes-In-Control dashboard, the managers can see the status of current processes, identify bottlenecks, and review critical indicators to optimize process performance
Xybion provides a complete Complaint Management module as part of our CQRM XD Quality Management suite. Customer complaints present unique challenges to manufacturers across multiple industry sectors. By nature, customer complaints represent dissatisfaction with either product quality or performance in a post-distribution environment. Valid complaints may lead to required changes in manufacturing product specifications or the costlier action of a product recall.
ECM-XD, based on Xybion’s Digital Acceleration Platform (XDP), provides a single, secure cloud platform architected to integrate end-to-end enterprise processes and content. In addition, the process rules, security, faceted search capability, powerful query builder, and report capabilities allow data to be retrieved at the right time by the appropriate people, which can include partners, external service providers, and other stakeholders via secured solution and mobile platforms. It offers full versioning, a flexible folder/file structure; workflow-based document review, approvals, and distributions; full-text searches and notifications, and multiple views (structures) of the files in the ECM structure; metadata to tag and perform auto-filling and document workflows.
Xybion’s CQRM XD is an enterprise-class quality management software platform that provides a complete Incident Management solution out-of-the-box. The management of risk is at the heart of incident management. Incident management transcends the mere ability to respond. Effective incident management software requires enterprise collaboration and communication to minimize risk and ensure sustained compliance.
Xybion provides a complete internal controls and internal audit software solution built inside of the CQRM XD Quality Management suite. The primary responsibility for the development and maintenance of internal control rests with an organization’s management. With increased significance placed on the control environment, the focus of internal control has changed from policies and procedures to an overriding philosophy and operating style within the organization. Emphasis on these intangible aspects highlights the importance of top management’s involvement in the internal control system. If internal control is not a priority for management, then it will not be one for people within the organization either.
Xybion provides a complete IT Governance software solution as part of its CQRM XD Quality Management software suite. In today’s challenging technology and business environment, many compliance processes are driven or highly influenced by IT systems. Such systems, whether QMS, ERP, or otherwise, are integral to initiating, recording, approving, and reporting crucial compliance information in accordance with internal and external mandates. The Sarbanes Oxley Act (SOX), mandates that an internal control framework over financial reporting is established and monitored.
Xybion provides a complete nonconformance software module as part of its CQRM XD Quality Management software solution. Global regulatory requirements include mandates to deal with products or raw materials that do not conform to product quality requirements. Nonconforming products or materials could lead to costly rework and even product recall. These nonconformities increase the organization’s risk of adverse impacts to business continuity, customer relations, market reputation, or other areas. Manufacturers across multiple industries must comply with guidelines such as cGMP, 21 CFR Part 820, ISO 9001, ISO 13485, and ISO 14001 which all include requirements for the management of nonconformances.
Xybion provides a complete Programs & Management Objectives module as part of its CQRM XD quality management software suite. Historically most organizations viewed the creation and monitoring of management programs as a necessary task to achieve ISO certification. The emergence of governance regulations and the move toward continuous improvement through the monitoring of key performance indicators necessitates that companies look for ways to measure their critical processes against the company goals and objectives to look for improvement and latent risk areas. Thus, companies are setting measurable objectives, recording data to measure against those objectives, and reporting on the status of their compliance as part of their tactical and strategic activities.
Xybion’s CQRM XD Quality Management software platform provides for a comprehensive quality management reporting and analytics solution. One of the major challenges facing highly regulated companies today is developing a single, consistent, and complete view of compliance-related information across all applications, databases, and enterprise systems.
Xybion provides a comprehensive Learning Management software module as part of its CQRM XD Quality Management software suite. Following 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. To document and demonstrate that the requirements are being met, those organizations must also keep training records.
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.