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Automated quality. Rapid regulatory compliance. Reliable risk insights.

Having worked with Pharmaceutical companies, TraxQM is designed for this sector. The landscape of quality management is demanding and TraxQM assists companies to comply with regulations.

Pharma focused

Avoiding “one-size-fits-all” QMS software, TraxQM is co-developed by a team who has in-depth domain experience. Our specialist industry knowledge allows unparalleled guidance and support. Ideal for pharma companies of all sizes.

Reliable regulatory compliance and risk management

For Pharmaceuticals companies risk management and compliance is a requirement. With a strong focus on ISO9001:15 and international regulatory frameworks, TraxQM provides a platform for companies in their drive for quality and compliance.

Streamline Quality Management workflows

Quality Management is an ongoing business function and demands rigour in its application. TraxQM removes the cumbersome and uncertainties of the various aspects of the discipline by intelligent automation of the processes and a Risk-based Quality Management approach.

Keep the whole team informed

TraxQM offers teams the ability to follow quality requirements in a formal manner, thereby ensuring adherence to the company’s quality goals. GxP compliance is made easy with many automated features including integrated DocuSign® .

Everything you need to meet regulatory compliance in one eQMS system

1

Document Manager

Easy-to-use document creation and management with automated version control, tagging, and electronic signatures. No need for paper copies with built-in DocuSign®.

2

Risk Management

Failure Mode Effect Analysis for effective risk analysis and evaluation. Formal evaluation with predefined scoring system.

3

CAPA Manager

Manages CAPA processes and highlight deviations, evaluates impact, analyse root causes, and reviews risk effectiveness. Follows recommended workflows in line with international standards.

4

Change Control

Implement change control with risk analysis. Monitor and review with cross-functional teams.

5

Training Module

In-house training with built-in programs, including externally sourced modules, skills matrix, and training records. Distribute training across your entire company and scale up with ease.

6

Audit Module

Supports internal reviews and audits with schedules, plans and checklists.