GxP Thermal Mapping Software
A purpose-built cloud platform for pharmaceutical thermal mapping and validation studies. Manage protocols, sensor deployments, data imports, and regulatory reports — from study initiation through to signed handover package.
Platform Overview
The GxP Mentor Thermal Mapping Software is a cloud-based platform designed to manage the full lifecycle of pharmaceutical thermal mapping and temperature validation studies. It replaces disconnected spreadsheets, manual protocols, and standalone PDF reports with a single structured, auditable system aligned to WHO TRS 961, FDA 21 CFR Part 11, and EU GMP Annex 11.
From protocol authoring through sensor placement, data import, statistical analysis, and electronic sign-off — every step is documented with an immutable audit trail. Studies move through a defined status workflow (Draft → Protocol Approved → In Progress → Under Review → Approved), with role-based access controlling who can view, edit, or approve at each stage.
On completion, the platform compiles a complete handover package — signed report, protocol, calibration certificates, raw data files, and full audit trail export — ready for submission to your quality management system or regulatory authority.
Core Features
WHO-Compliant Protocol Builder
Multi-section protocol wizard aligned to WHO TRS 961 Annex 9. Covers scope, objectives, methodology, acceptance criteria, and stress test requirements. Locked on approval with full amendment workflow.
Sensor Map Builder
Interactive canvas for uploading floor plans and placing sensors using WHO grid placement rules. Positions are recorded with coordinates and locked to the approved protocol.
CSV / XLSX Data Import
Import sensor data via CSV or Excel with an interactive column mapping interface. Pre-import validation checks timestamp continuity, plausibility ranges, duplicates, and data gaps before committing.
Thermal Analysis Engine
Calculates MKT, MKH, and Arrhenius reaction rate (ARR) per sensor. Detects and logs excursion events, ranks hot spots and cold spots, and evaluates study pass/fail against acceptance criteria.
Electronic Signatures
FDA 21 CFR Part 11-aligned electronic signature workflow. Each signature requires password re-authentication and captures the signer's role, title, timestamp, and the hash of the signed document.
Handover Package Compilation
Automated assembly of the complete regulatory handover package: signed mapping report, approved protocol, calibration certificates, raw data files with SHA-256 hash manifest, and full audit trail export.
Study Lifecycle in the Platform
Protocol & Setup
Create the study, assign an environment and sensor fleet, author the WHO-aligned protocol, and build the sensor placement map. The protocol is locked by electronic signature before execution begins.
Data Collection & Import
Run the study in the field. When complete, import logger data via CSV or Excel. The platform validates all rows before import and stores the raw file with a SHA-256 integrity hash.
Analysis & Review
The analysis engine calculates MKT, excursion events, hot/cold spot rankings, and pass/fail status. Interactive multi-sensor charts and a full results table support QA review.
Sign-Off & Handover
The mapping report is electronically signed by the preparer, reviewer, and approver. The platform then compiles and packages all study artefacts into a compliant handover bundle.
Access the platform
Private BetaSign in at map.gxpmentor.com — access is by invitation during the beta period.
Study Types & Environments Supported
Regulatory Alignment
Every feature of the platform is designed against the regulatory requirements for computerised thermal mapping systems. The compliance profile is configurable per organisation to match the standards applicable to your operations.
Get Access to the Mapping Platform
The GxP Thermal Mapping Software is currently in private beta, available to selected GxP Mentor clients. Contact us to discuss early access and onboarding your organisation.