Role
UX Professional (Team Lead)
Company
Codesplice
Type
SaaS Product
Time
10 months
My Part
Directed the integration of AI-driven risk analysis, enabling proactive identification and mitigation of potential risks and KPIs, which significantly reduced errors from manual risk assessments.
Implemented ISO-compliant CRM contact verification processes, improving data accuracy and organizational data integrity.
Designed and deployed an audit and management framework, strengthening risk-based internal audit processes while enabling tracking of company objectives and contexts.
Led the development of customizable dashboards and heatmaps, providing stakeholders with real-time insights and enhanced system monitoring capabilities.
Demonstrated Figma prototypes to stakeholders, gathering and incorporating feedback to refine solutions and ensure user-centric, effective designs.
A bit of a background
What is TraxQM?
TraxQM is a risk-based Quality Management System (QMS) designed to drive operational excellence for businesses.
It helps the companies manage their compliance needs and meet current regulatory requirements.
Features
TraxQM comprehensive solution enhances critical quality processes, covering:
CAPA,
Complaint,
Deviation,
Change Control,
Risk Management.
What makes TraxQM unique?
Kanban-based task management, and risk-based methodologies with support for internal risk-based audits & management reviews.
What I designed?
Risk-based 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.
Management review
A setup designed to record the Management Review meeting minutes and monitor the actions in the organisation.
Customer relationship Manager (CRM)
Records the data of Assets and Contacts of the Organisation and provides a way to verify the data based on external database.
AI Assistance in Risk Analysis
Integrated AI to assess risks and KPIs to track the effectiveness of processes and controls to prevent risks.
Results I achieved?
Improved compliance transparency via dashboards and real-time monitoring.
Enhanced stakeholder satisfaction, confirmed through on-site workshops and prototype testing.
Reduced manual risk assessment errors significantly through AI integration.
My Process
01
Research
02
Define and Ideate
03
Design
04
Test and Launch
User Research
Conducted in-depth interviews with pharmaceutical auditors, compliance officers, and QA professionals to understand their audit processes, pain points, and requirements.
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).
Insights
S
Strong integration with QMS (links audits with CAPAs, deviations, risks).
Enterprise-proven scalability (multi-site, role-based access, global deployments).
Increasing AI/automation (risk scoring, audit scope prioritization, auto-classification).
Comprehensive compliance workflows (audit planning, execution, evidence, closure).
W
High complexity → long setup & training cycles.
Resistance to change (users attached to Excel/manual processes).
Heavy customization needs increase cost/time-to-value.
Perceived vendor lock-in due to critical compliance data.
O
Mid-market demand for simpler, faster-to-implement solutions.
AI-driven predictive auditing (forecast risks, suggest preventive actions).
Prebuilt industry templates & ERP/PLM integrations to reduce adoption friction.
Expansion into ESG & sustainability compliance auditing.
T
DIY/low-code alternatives (Excel + automation + workflow tools).
Regulatory fragmentation (FDA, EU MDR, local standards) increases complexity.
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.
Users who completed their User Journey
Domain Knowledge
Risk-Based Auditing
Risk Priority Number (RPN) = Severity (S) X Occurrence (O) X Detection (D)
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.
Audit User Journey
Final To-Do List
Reports
Auto generated report should be presented in audit and management review.
Example: Stages of audit like Identification, Evaluation, Action plan, Implementation and Review should be recorded.
Integration
Integrate data from different modules of QMS in management setup for an effective tracking of actions and processes.
Dashboards
Real-time data of QMS should be presented like risks, KPIs, events, controls, audits to visualise and track activities.
cRM verification
CRM should integrate database and provide verification of the customers and suppliers in the organisation.
Artificial Intelligence for TraxQM
AI data analysis
What data AI should analyse in order to provide outcome?
Eg: What data AI needs to study to help the user in risk assessment?
aI outcome
What exactly the outcome should be?
Eg: How AI can suggest preventive measures in order to control the risks.
Scope Creep!
Another Task: Design ERP System
Too many Tasks = Monster Charts :(
Whoops!
I dug too deep! :(
I got lost in the loop. I started getting into deeper scenerios and loosing the grip over the track. I got too many information about too many areas and I started making up flows for different modules at the same time.
Peers to the rescue! :)
My peers helped me to get out of the loop.
I realised I have to start with the high level overview instead of deeper scenerios.
Once the modules are finalized, I can start digging up scenerios one module at a time.
Here
We
Go!
One step at a time
Continuing with TraxQM
Concept derived from Jira Kanban board and Microsoft Teams Task setup
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)
Integrated with Syncfusion
Providing flexibility to users
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.
Similar to Outlook Mails
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.
Consistent with Audit Module
Overall Mockups
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.
Keeping Wireframes Simple and Intuitive
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
