TraxQM
Quality Management System

Role: UX Professional
Time: 10 months
Company: Codesplice
Type: SaaS Product

My part:
- Implemented ISO-compliant verification processes for CRM contacts, improving data accuracy by 28%.
- Integrated AI-driven risk analysis to identify and mitigate potential risks and KPIs proactively, significantly reducing errors of manual risk assessments.
- Developed audit and management setup enhancing risk-based internal audit processes, track company objectives and contexts
- Crafted customizable dashboards and heatmaps to provide real-time insights and effective system monitoring.
- Demonstrated Figma prototypes, eliciting constructive feedback to refine designs.

TRAXQM

AI-Powered Features of TraxQM

TraxQM leverages AI to enhance risk management, compliance and decision-making ensuring proactive quality control and regulatory adherence.

1

Risk Management

AI-driven risk analysis for proactive quality control
Analyzes existing risks and suggests targeted control measures to mitigate potential issues
Enhance compliance, strengthen quality processes, and proactively address risks before they lead to non-conformance

2

KPIs

Intelligent KPI recommendations
Suggests relevant Key Performance Indicators (KPIs) based on organisational objectives and risk profiles
Ensures a focused approach to monitoring, optimising resources and improving critical areas of business success

3

Document Management

AI-powered document review for GxP compliance
Review documents and provide feedback on content quality and compliance with GxP guidelines
Ensures that documents meet regulatory standards, improving accuracy and adherence to industry best practices

4

Training

Generate comprehensive training with AI
Quality content in just a few clicks? Check! Text, images, tests—cover every element of course creation and accelerate along the path to L&D success

What I designed?

audit

A risk-based audit system which let users to record processes, take necessary actions and generate audit report based on compliance and non-compliance results.

AI ASSISTANCE IN RISK MANAGEMENT

Integrated AI to assess risks and KPIs to track the effectiveness of processes and controls to prevent risks.

management review

A setup designed to record the Management Review meeting minutes and monitor the actions in the organisation.

CRM

Records the data of Assets and Contacts of the Organisation and provides a way to verify the data based on external database.

CHAPTER 1:
Research

User research, Competitive analysis and Insights

01

User research

Conducted in-depth interviews with pharmaceutical auditors, compliance officers, and QA professionals to understand their audit processes, pain points, and requirements.

02

Regulatory analysis

Conducted a comprehensive analysis of regulatory requirements governing audit management in the pharmaceutical industry, including FDA regulations, EMA guidelines, and international standards (e.g., ISO 19011).

03

Competitive analysis

Evaluated existing audit, risk and management solutions in the market, focusing on features, user experience, compliance capabilities, and integration with QMS platforms with SWOT.

Insights

Analyzation

Users spend significant time manually analyzing data to identify risks and recommend mitigation measures.

KPIs

It is challenging for users to track KPIs based on different risks and intended results.

Visualise data

Users find it difficult to visualise and integrate necessary data in the management setup.

CHAPTER 2:
Define and Ideate

Define goals and brainstorm ideas

Define

Based on our research insights, I defined clear user personas, each representing a distinct user archetype with unique needs and requirements. 

What to do?

Generate creative solutions to address the identified user needs and pain points.

AI for Risk assessment and KPI

Audit Process Flow

CHAPTER 3:
Design

Low fidelity and High fidelity prototypes

Prototypes

Incorporated branding elements, colors, typography, and imagery to create a visually appealing and responsive design.
I implemented functional elements such as navigation menus, data input forms, search functionalities, and task flows to simulate real-world interactions.

Concept derived from Microsoft Teams Task setup and Jira Kanban board

Dashboard data

Designed a powerful data visualisation tools that offer a comprehensive overview of the organisation's quality health.
Data:
Events- Complaints, Deviation, CAPA
Change controls
Tasks- According to status
Risks- Statistics and Heatmaps based on RPN

Audit

Designed to empower organisation with a robust, risk-based approach to managing internal and external audits.
Implemented audit processes with comprehensive features designed to ensure thorough compliance and continuous improvement.

Management

Built robust set of tools to help organisations manage their structures, assets, and strategic plans effectively. 
Tailored to meet real-world scenarios, our module ensures compliance and enhances operational efficiency.

Forms

Created Forms setup where users can design and implement custom forms to streamline quality processes, ensuring compliance with the GxP regulations.
It helps to digitise internal processes and enhance traceability with built-in validation and approval workflows.

CHAPTER 4:
Test and Launch

Testing, Iteration and Launch

Usability testing

Conducted comprehensive testing for responsiveness using BrowserStack, a cloud-based testing platform that allows for testing across a wide range of browsers and devices.

Conducted usability testing sessions with users on-site and virtually to gather feedback on the prototypes and validate design decisions.

These sessions helped identify usability issues, uncover user preferences, and refine the user interface based on real-world usage scenarios.

Presentation

Presented the Audit module, focusing on the key features, functionalities, and workflows infront of team and stakeholders.
Provided context on the goals and objectives of the Management module, emphasizing how the design aligns with user needs and business requirements.

User feedback

Based on the feedback received from usability testing and stakeholder reviews, I iteratively refined the design which allowed me to address user concerns, incorporate new insights, and continually enhance the user experience.

Conclusion

The whole process involved extensive research, competitive analysis, design thinking, and iterative prototyping.
By incorporating user-centered design principles and industry-specific insights, the resulting system provides pharmaceutical companies with a powerful tool to streamline operations, ensure compliance, and drive business growth.

TRAXQM