A bit of a background

TraxQM is a risk-based Quality Management System (QMS) designed to drive operational excellence for businesses. TraxQMcomprehensive solution enhances critical quality processes, covering CAPA, Complaint, Deviation, Change Control, and Risk Management. 

TraxQM includes subscriptions for TalentLMS and DocuSign with 21 CFR Part 11 compliance, providing an all-encompassing solution for streamlined quality management. Our integrated document management uses SharePoint Online with full offline sync support. 

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.
This involved interviews, surveys, and observational studies to understand their pain points, workflows, and goals related to quality management.  

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, we defined clear user personas, each representing a distinct user archetype with unique needs and requirements. These personas helped us empathize with our users' perspectives and prioritize features and functionalities accordingly.  

Concepts

In the ideation phase, we facilitated collaborative workshops and brainstorming sessions with cross-functional teams to generate creative solutions to address the identified user needs and pain points. We encouraged an open exchange of ideas and explored diverse design possibilities.

CHAPTER 3:
Design

Low fidelity and High fidelity prototypes

Lo-fi prototypes

Using the insights gathered during the ideation phase, I developed interactive prototypes. ​I also 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

Integrated with Syncfusion

Dashboard data

Provides powerful data visualisation tools that offer a comprehensive overview of your organisation's quality health. Empower your management team with actionable insights and real-time data to drive informed decision-making and maintain regulatory compliance.

Audit

Empowers your organisation with a robust, risk-based approach to managing internal and external audits. It enhances your audit processes with comprehensive features designed to ensure thorough compliance and continuous improvement.

Management

Offers a 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.

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. By accessing real devices and browsers on BrowserStack, I was able to verify the responsiveness of my designs and identify 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 and improved the design. This iterative approach allowed me to address user concerns, incorporate new insights, and continually enhance the user experience.

Presentation

Scheduled a meeting with key stakeholders and end-users who will be interacting with the QMS system.
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 where users can share their thoughts, opinions, and suggestions about the design of Audit and Management modules of the QMS system.
Used 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

Development of the Audit module, Management setup and AI integration in SaaS QMS system for pharmaceutical industries 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

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