The SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency.
1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance.
2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features.
3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management.
4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations.
5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers.
Each of these modules may be purchased individually or in any combination to meet your needs.
On-premise and cloud-based options are available.
Free demos are available for download or contact us for a cloud-based demo.
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QFacts
QFacts is an all-encompassing cloud-driven Quality Management System tailored for pharmacies, compounding facilities, and other regulated industries. It manages the full spectrum of the quality lifecycle, offering features such as controlled document management with versioning and approval processes, training and competency tracking aligned with specific curricula, and comprehensive event and complaint management that includes root cause analysis, CAPA management, and change control, all while maintaining detailed audit trails. Designed to meet GAMP 5 requirements, it also adheres to European GMP and GDP regulations, utilizing role-based access controls that integrate across various organizations, locations, and departments. Quality managers benefit from customizable review workflows, the ability to monitor due dates, and compliance oversight through real-time dashboards. Every action within the system is logged meticulously, ensuring a transparent accountability chain for inspectors and auditors, from document approval to training completion and the resolution of corrective measures. This thorough level of oversight not only boosts operational efficiency but also instills greater reliability within quality management processes. As a result, QFacts positions itself as an essential tool for organizations striving to maintain high standards of quality and compliance.
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ComplianceWire
ComplianceWire, an LMS designed for cloud use and compliant with Part 11, was created by UL Compliance to Performance. This training system caters specifically to the needs of companies in the pharmaceutical, biologics, and medical device sectors. It supports the oversight and skill development of learners alongside tracking compliance statuses. With its distinctive role-based methodology for compliance qualification and performance oversight, ComplianceWire enables users to satisfy rigorous regulatory demands while effectively handling challenging training tasks. Additionally, this system streamlines the training process, ensuring that employees remain well-informed and compliant with industry standards.
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