Remote access software suite

monitoringmappingdata management

Overview
Mapping Suite is a software solution designed to automate mapping studies of regulated environments. It centralizes planning, execution and management of mapping studies to reduce manual operations, improve traceability and ensure compliance throughout the process.

Main features

• Study automation: bulk device configuration using preloaded templates and reusable study parameters.
• Automated data recordings: predefined logging settings applied automatically to reduce manual tasks.
• One-click reports: generation of audit-ready, timestamped, non-editable reports exportable to PDF or CSV.
• Real-time visibility: access to data and live monitoring before, during and after the study.
• Scalable workflows: support for studies of varying sizes and complexity, with simplified multisite scaling.
• Remote access: view and control data from any device for faster response.
• Pre-check and live monitoring: configuration checks and rapid deviation detection during studies.
• Audit trails and data integrity: timestamped, attributed logs ensuring traceability of system actions.

Reports
Generated reports include all information required for audits: sensor identifiers, calibration dates, timestamped readings, deviations and study history. They comply with regulatory requirements and can be customized to align with standard operating procedures.

Compliance and supported standards
Mapping Suite is designed to meet data integrity and traceability requirements in regulated environments, including: 21 CFR Part 11, EU Annex 11, FD X 15-140, WHO guidance, ISPE and USP recommendations. Audit logs are retained and locked to meet ALCOA principles.

Kits and sample offers
The solution is offered with mapping kits (examples) adapted to installation type:

• MKIT-O1 — Ambient temperature/humidity: software access with rights for 16 loggers, software updates, 16 loggers, 16 calibrated temperature/humidity sensors, 1 gateway.
• MKIT-O2 — Refrigerators or freezers (-20°C): software access with rights for 16 loggers, software updates, 16 loggers, 16 calibrated Smart-DS sensors, 1 gateway.
• MKIT-O3 — Ultra-low temperature freezers (-80°C): software access with rights for 16 loggers, software updates, 16 loggers, 16 calibrated PT-100 sensors, 1 gateway.

Benefits

• Reduces time and effort by automating repetitive tasks.
• Improves study quality and consistency through centralized templates and workflows.
• Provides audit-ready reports to simplify regulatory inspections.
• Scales to support multi-site deployments and large studies.

Technical features / specifications

• Exportable report generation: PDF and CSV, timestamped and non-editable.
• Audit trails: timestamped, attributed and locked logs (compliance with 21 CFR Part 11, EU Annex 11, ALCOA).
• Support for all-in-one kits including software, calibrated sensors, data loggers and gateway.
• Bulk device configuration via preloaded templates for fast, consistent setup.
• Remote access and real-time data supervision from any device.
• Adaptability: suitable for small units and complex multisite deployments.
• Regulatory coverage: FD X 15-140, FDA recommendations, WHO guidance, ISPE guide, USP and GxP requirements.
• Hosting options and an annual subscription model enabling predictable budget management (annual rental model).