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TraxQM

Pharma quality management with proactive regulatory compliance and risk management automation.

Solution by Codesplice
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Overview

TraxQM is a cloud-based pharma quality management software developed by Codesplice, a London-based software house with over 25 years of experience in the pharmaceutical and life sciences sector. It is designed for regulated pharma and life science businesses that need to take a proactive approach to regulatory compliance and quality management.

Codesplice builds automated systems specifically tailored to the pharmaceutical sector, with the goal of optimising operations, achieving regulatory compliance, and meeting quality targets. TraxQM is part of a broader suite of pharma-focused applications that includes TraxCM, FMVerify, and Trax2D.

Core Capabilities

  • Supports proactive regulatory compliance management within pharmaceutical quality processes
  • Automates required process flows once implemented and configured
  • Provides risk management tools designed to maintain a high degree of regulatory compliance
  • Integrates with other Codesplice applications to encourage team collaboration and improve productivity

Platform and Deployment

  • Delivered as a cloud-based solution, removing dependencies on company IT infrastructure
  • Hosted on AWS or Azure with a 99.9% uptime SLA
  • Designed in line with GAMP5 guidelines and security best practices
  • Regularly tested against OWASP vulnerabilities with ongoing patch maintenance
  • Eliminates downtime associated with on-site installation and maintenance

Product Characteristics

  • Tailored specifically to the pharmaceutical industry rather than adapted from generic off-the-shelf ERP software
  • Competitively priced to suit organisations of varying sizes
  • Scalable to grow alongside the business
  • Designed to be implemented and operational within days rather than weeks or months
  • Built using an iterative development approach covering planning, sprint, iteration, and release stages

TraxQM is part of the Codesplice application suite, which also covers stock and order management (TraxCM), FMD compliance for wholesale operations (FMVerify), and serialisation (Trax2D). The integrated nature of these applications is intended to support end-to-end quality, compliance, and operational management for pharmaceutical businesses.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotech
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory Affairs
Compliance standard(s)
GxP