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 30%.
- 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.
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?
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
User research
Conducted
in-depth interviews with pharmaceutical auditors, compliance officers, and
quality assurance professionals to understand their audit processes, pain
points, and requirements.
Explored
topics such as audit preparation, execution, follow-up, regulatory
compliance, and integration with other quality management processes which involved interviews, surveys, and
observational studies.
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).
Identified key compliance requirements and best
practices to ensure the product aligns with industry standards.
Competitive analysis
Evaluated
existing audit, risk and management solutions in the market, focusing on features,
user experience, compliance capabilities, and integration with QMS
platforms.
Identified
strengths, weaknesses, and opportunities for differentiation to inform the
design of TraxQM.
Analyze
Users spend significant time manually analyzing data to identify risks
and recommend mitigation measures.
Prioritize risks
Users struggle to prioritize
risks effectively, leading to delays in implementing mitigation measures.
Historical data
Users find it challenging to access and analyze historical data to identify trends and patterns.
CHAPTER 2:
Define and Ideate
Define goals and brainstorm ideas
Goals
Based on our research
insights, I defined clear user personas, each representing a distinct user
archetype with unique needs and requirements.
These personas helped me empathize with users' perspectives and prioritize features and
functionalities accordingly.
Concepts
In the ideation phase, I facilitated collaborative workshops and brainstorming sessions with
cross-functional teams to generate creative solutions to address the identified
user needs and pain points.
AI Analysis
AI Assistant should analyze data, providing insights based on previous outcomes. This enables users
to make data-driven decisions.
AI Data
AI Assitant should prioritize risks based on their severity, likelihood, and potential
impact to address the most critical risks first,
optimizing resource allocation.
CRM verification
CRM should integrate database and provides verification of the customers and suppliers in the organisation.
Reports
Different stages of audit like Identification, Evaluation, Action plan, Implementation and Review should be recorded. Auto generated report should be presented in audit and management review.
Integration
Integrate data from different modules of QMS and record in review minutes for an effective tracking of actions and processes.
Dashboards
Real-time data of QMS should be presented like risks, KPIs, events, controls, audits to get a clear picture of the organisational activities.
CHAPTER 3:
Design
Low fidelity and High fidelity prototypes
Lo-fi prototypes
Using the insights gathered
during the ideation phase, I developed interactive prototypes and added annotations to explain the functionality of each element and how users will interact with the audit module and AI assistant.
Finally I reviewed the wireframes with stakeholders again, gathered additional feedback, and made necessary iterations to finalize the lo-fi prototypes.
Hi-fi 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.
Dashboard data
Designed a powerful data visualisation tools that offer a comprehensive overview of the organisation's quality health.
It empowers the management team with actionable insights and real-time data to drive informed decision-making and maintain regulatory compliance.
Audit
Audit module empowers organisation with a robust, risk-based approach to managing internal and external audits.
It enhances audit processes with comprehensive features designed to ensure thorough compliance and continuous improvement.
Management
Management setup offers a robust set of tools to help organisations manage their structures, assets, and strategic plans effectively.
It is tailored to meet real-world scenarios, our module ensures compliance and enhances operational efficiency.
CHAPTER 4:
Test and Launch
Testing, Iteration and Launch
Responsiveness
I conducted comprehensive testing of the SaaS product's responsiveness using BrowserStack, a cloud-based testing platform that allows for testing across a wide range of browsers and devices.
I verified the responsiveness of my designs and solved any layout or functionality issues across different platforms.
Usability testing
I conducted usability
testing sessions with representative users 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.
Iteration
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.
Presentation
Presented the design of the Audit module, focusing on the key features, functionalities, and workflows that have been developed based on user research and design principles.
Provided context on the goals and objectives of the Management module, emphasizing how the design aligns with user needs and business requirements.
User feedback
Facilitated a feedback session with open-ended questions to encourage users to provide detailed feedback on specific aspects of the design, such as usability, clarity, and functionality.
Captured feedback in real-time using note-taking tools, digital surveys, or collaborative whiteboarding software.
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
