Optiqs360 Digital is a SaaS digital thread platform that provides seamless visibility across disparate systems, empowering users to connect teams, streamline workflows, and automate report generation.
With a single, unified view, users can access comprehensive product data spanning R&D, Post-Market, Regulatory, Supply Chain, Manufacturing, and more—without the need to log into multiple systems. This holistic perspective enables them to efficiently design, investigate, remediate, and manage products with greater clarity and insight.
Designed to unify data from multiple enterprise systems, creating a comprehensive Digital Thread across the organization. Supports integration of both internal and external content for a connected ecosystem.
Extends beyond traditional data management, incorporating quality, regulatory, and operational data across the enterprise. As a modern SaaS solution, it is built for scalability and broad applicability.
Delivers powerful data visualization through dashboards, trend analysis, and real-time alerts—tracking product flow from raw materials to customer feedback. Automates reporting, analytics, and the creation of critical compliance and business documents such as APRs.
Facilitates yearly evaluations of drug quality, efficacy, and safety by aggregating critical data, including batch quality, deviations, complaints, recalls, and stability testing results.
Supports compliance with FDA and EU post-market surveillance requirements by streamlining reporting on complaints, adverse events, malfunctions, and other device-related issues.
Enhances root cause analysis, such as the 5-Whys methodology, by integrating batch records, raw material COAs, process data, deviation reports, OOS investigations, and supplier audit reports
Customized solutions, powered by extensive expertise in drug commercialization and healthcare, to strengthen your strategy and drive success.
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