Xybion Software Demo - Quality Management System For Opentext

This video provides an in-depth demonstration of Xybion's Quality Management System (QMS) built on the OpenText platform, showcasing its capabilities for companies operating in highly regulated industries, particularly the life sciences sector. Presented by Sunil Tiwari, Director of Technical Operations and Compliance Solutions at Xybion, the session walks viewers through the core functionalities of the QMS product and how it facilitates comprehensive quality management directly within the OpenText environment. The primary objective is to illustrate how this integrated solution drives operational efficiency, ensures regulatory compliance, and streamlines critical quality processes.

The QMS solution is designed to manage essential quality processes such as deviations, Corrective and Preventive Actions (CAPAs), non-conformances, and change control. It leverages OpenText's inherent capabilities for imaging, document management, and workflow, providing a graphical and intuitive interface for end-users to configure quality management workflows. A key highlight is its compliance with major regulatory standards, including 21 CFR Part 11, a critical requirement for the life sciences sector. The system boasts high configurability, allowing organizations to tailor workflows to their specific needs rather than adopting a rigid, one-size-fits-all approach, which is crucial given the subtle differences in business processes across organizations.

The demonstration focuses on a sample CAPA workflow, starting from the logging of a safety incident. The process unfolds through several stages: an initial observation, creation of a CAPA, investigation by a designated individual, and ultimately, the closure of the CAPA. While the full workflow including root cause analysis and detailed action plans is configurable, the demo streamlines it to show the core navigation and decision points. Throughout the process, the system facilitates role-based assignments, automated email notifications, and maintains a clear hierarchy of linked items (e.g., CAPA linked to observation). The presenter emphasizes features like automated ID generation for documents and records, configurable dashboards for real-time monitoring of CAPA statuses, and the ability to attach evidence documents with templated naming conventions.

A significant portion of the demonstration highlights the system's robust e-signature capabilities, which are essential for regulatory compliance. The e-signature process involves multiple signatories (e.g., CAPA owner, safety reviewer, CAPA closer) and generates a PDF rendition that captures the signatures, date, time stamp, meaning of the signature, and title, along with all relevant form information from the CAPA process. This ensures an undeniable audit trail. Furthermore, the QMS includes comprehensive audit trails for all configuration changes, recording old and new values, timestamps, and user information. The system also supports multi-browser and multi-language functionality, offers various reporting formats (HTML, PDF, Word, Excel, CSV), and provides tools for exporting and importing configurations between different environments (e.g., QA to production), simplifying deployment and maintenance.

Key Takeaways:

• Integrated QMS for Regulated Industries: The Xybion QMS is specifically designed for companies in highly regulated sectors, particularly life sciences, to manage critical quality processes like CAPAs, deviations, non-conformances, and change control.
• Leveraging OpenText Platform: The solution directly integrates with the OpenText Content Server, utilizing its document management, security, workflow, and forms capabilities, which can lead to reduced support costs, lower user training, and faster deployment.
• 21 CFR Part 11 Compliance: A core feature of the QMS is its adherence to major regulatory standards, explicitly including 21 CFR Part 11, which is vital for electronic records and signatures in the pharmaceutical and life sciences industries.
• Highly Configurable Workflows: The system is 100% configurable, allowing organizations to customize business process workflows (e.g., CAPA, root cause analysis) to match their unique operational complexities and requirements, avoiding a rigid, generic approach.
• Automated ID Generation and Document Control: The QMS includes an automated ID generator for unique identification of observations, CAPAs, and other records, along with the ability to apply ID templates to uploaded documents, streamlining naming conventions and document management.
• Comprehensive Audit Trails: The system maintains detailed audit trails for all configuration changes and workflow actions, capturing old and new values, date/time stamps, and user information, which is crucial for regulatory scrutiny and accountability.
• Robust E-Signature Capabilities: Electronic signatures are fully integrated for legally binding approvals and sign-offs. These signatures are captured with associated metadata (date, time, meaning, title) and rendered into a PDF, ensuring regulatory compliance for record integrity.
• Role-Based Assignments and Notifications: Workflows support role-based assignments for tasks and trigger automated email notifications, ensuring that relevant stakeholders are informed and can act promptly on pending items.
• Actionable Dashboards and Reporting: Configurable dashboards provide real-time visibility into the status of various quality processes (e.g., CAPA by observation type), allowing users to monitor progress and drill down into specific records. Reports can be generated in multiple formats (HTML, PDF, Word, Excel, CSV).
• Simplified Configuration Management: The export and import functionality for configurations allows organizations to easily move system setups from development or QA environments to production, significantly reducing recreation effort and ensuring consistency.
• Multi-Language and Multi-Browser Support: The application supports multiple languages and is tested on various browsers (e.g., IE11, Chrome), enhancing its usability and accessibility for global operations.
• Data Exchange Capabilities: The QMS can exchange information with other tables or objects within the OpenText LiveLink environment, enabling lookups of organizational data or people, and fostering a more integrated enterprise data landscape.

Tools/Resources Mentioned:

• Xybion QMS (Quality Management System)
• OpenText Content Server (specifically CS10 and CS10.5 versions)

Key Concepts:

• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• CAPA (Corrective and Preventive Action): A process for investigating and correcting non-conformances (corrective action) and preventing their recurrence (preventive action).
• 21 CFR Part 11: Regulations issued by the FDA that set forth requirements for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• GRC Suite (Governance, Risk, and Compliance): A comprehensive approach to managing an organization's overall governance, enterprise risk management, and compliance with regulations.
• Deviations: Departures from approved instructions or established standards.
• Non-conformance: A failure to meet a requirement.
• Change Control: A formal process used to ensure that changes to a product, system, or process are introduced in a controlled and coordinated manner.
• E-signature: Electronic data that is logically associated with other electronic data and which is used by the signatory to sign the electronic data.
• Audit Trail: A chronological record of system activities, including who performed what action, when, and what the outcome was, crucial for regulatory compliance.

Examples/Case Studies:

• Sample CAPA Workflow: The video demonstrates a simplified CAPA workflow initiated by a "safety incident." The steps include logging the incident, creating an observation, generating a CAPA, assigning an investigator, the investigator's report, the CAPA owner's review, and finally, the closure of the CAPA with e-signatures from multiple parties. This example illustrates the system's ability to manage the lifecycle of a quality event from initiation to closure.