SciNote ELN

SciNote ELN is a comprehensive electronic lab notebook tailored for clinical diagnostics laboratories and developers of diagnostic kits, including molecular, immunoassay, and point-of-care kits. It facilitates efficient management of diagnostic studies, assay development, and kit manufacturing documentation, ensuring compliance with industry standards such as FDA 21 CFR Part 11, GxP, ISO 13485, and ISO 27001:2022.

Key features include built-in audit trails, electronic signatures, and access control, keeping labs ready for inspections and submissions. SciNote centralizes protocols, raw data, formulation records, and batch materials, offering full traceability across kit development and testing. It allows users to manage inventory with ease, tracking antibodies, primers, buffers, and raw materials.

Users can organize data by kit type, development phase, or product version, streamlining assay optimization, performance verification, and stability testing. The platform supports coordination across R&D, manufacturing, QA/QC, and regulatory departments through role-based access and project-based visibility, ensuring secure data access.

SciNote enforces standardized procedures and workflows to minimize errors and expedite validation timelines. It provides templates and task tracking to help new team members integrate quickly. The platform's intuitive design simplifies experiment organization and documentation, enhancing team coordination through task sharing and assignment.

Additional functionalities include:

• Regulatory Readiness: Meet FDA, IVDR, CLIA, and ISO requirements with organized, version-controlled documentation, ready for audits or submissions.
• Project Management: Automate documentation and workflow tracking, replacing manual logs and spreadsheets. Visualize workflows, create templates, assign tasks, and monitor progress on the dashboard.
• Data Integrity & Traceability: Ensure full traceability of all kit development phases with secured audit trails. Organize data in a structured manner and customize the platform to fit lab processes.

SciNote empowers lab managers, R&D scientists, QA experts, and regulatory teams by streamlining documentation, ensuring traceability, and supporting regulatory audits throughout the kit development lifecycle.