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 organizational 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
TraxQM is a risk-based Quality Management System (QMS) designed to drive operational excellence for businesses. TraxQM comprehensive solution enhances critical quality processes, covering CAPA, Complaint, Deviation, Change Control, and Risk Management.
What sets TraxQM apart is its user-friendly interface, Kanban-based task management, and risk-based methodologies with support for internal 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.
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.
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.
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).
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
Data Analysis
Users spend significant time manually analyzing data to identify risks and recommend mitigation measures.
Monitor KPIs
It is challenging for users to track KPIs based on different risks and intended results.
Data visualisation
Users find it difficult to visualise and integrate necessary data in the management setup.
Risk-Based Auditing
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.
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 provides verification of the customers and suppliers in the organisation.
Audit User Journey
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.
enhance risk management, compliance and decision-making ensuring proactive quality control and regulatory adherence
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
01
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
02
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
03
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
04
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.
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
