Tepsivo Reviews

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.

Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.

DrugCard is an AI-powered pharmacovigilance platform designed to help pharmaceutical companies, CROs, and drug safety teams automate routine safety intelligence workflows, reduce manual screening, and maintain audit-ready pharmacovigilance processes. The platform supports global and local medical literature monitoring, regulatory intelligence, and adverse event data management in one connected workflow. DrugCard helps PV teams detect relevant safety information faster, review AI-generated article summaries, prioritize safety-relevant publications, translate local sources, create cases from literature, and maintain full traceability across screening and review activities. DrugCard’s literature monitoring solution covers 121+ countries, 2,200+ local medical sources, and 100+ languages, combining global sources such as PubMed with local, non-indexed journals that are often difficult to monitor manually. The system provides configurable projects, automated monitoring, keyword highlighting, AI pre-assessment of safety relevance, automated reports, notifications, QC workflows, audit trails, and documentation-ready outputs. In addition to literature monitoring, DrugCard includes AI-powered Regulatory Intelligence for tracking updates from health authorities and an Adverse Event Database for centralized safety data collection, E2B(R2/R3) support, reporting, analytics, and compliant case management. DrugCard is built for pharmacovigilance teams that need scalable, transparent, and compliant automation while keeping human experts in control of final medical and regulatory decisions.