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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environment and Sustainability
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
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ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
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Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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Medical Device & Manufacturing East
20 May, 2025
New York, NY
About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to customer success.
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Across industries, from automotive and manufacturing to pharma and biotech, the fundamental principles of TQM remain the same. These include:
TQM in the pharmaceutical industry is no different. While there are several regulatory requirements (21 CFR Part 210/211, 600; EU Directive 2003/94/EC, EU Annex 13; ICH Q8, Q9, Q10, Q11; etc.) that govern this industry, TQM is about going beyond compliance needs.
It is about building an enterprise-wide culture wherein a “quality-first mindset” drives all actions and activities across the product lifecycle.
Embracing TQM principles and setting up the required processes will play a key role in delivering customer delight while reducing manufacturing costs and improving financial performance. In today’s digital world, it is paramount that pharma companies that have TQM on their agenda use the power of automation and digital transformation.
The question is: What processes should we automate as part of our TQM efforts?
Short answer: Ideally, everything you can, but do it step by step.
Long answer: Over time, make sure you automate the following processes – Inspections and Audits, CAPA, Change, Training, Complaints Handling, Management Reviews, Documentation, Risk Management, and Regulatory Processes. Implement a next-generation EQMS that makes it easy for quality leaders and other stakeholders to access data at their fingertips. To implement TQM, it is important to have an EQMS platform that easily integrates with the ERP and CRM. A complaint that comes in from the CRM must flow through to the Complaints Handling and CAPA modules, in addition to triggering notifications for specific actions to be taken.
At ComplianceQuest, we’ve deep expertise in serving the pharmaceutical and biotech sector, in automating and digitalizing the entire QMS workflow. Based on this experience, we highlight here the common reasons why TQM efforts fail and how using the right digital tools can prevent failure.
Integrating people, processes, and systems is a key TQM principle. Let us say you spot a quality issue during an inspection. Without wasting any time, this issue must be fed into the CAPA management system to plan the next steps. In order to act with agility, automation is a must.
ComplianceQuest offers a truly connected, comprehensive EQMS platform that makes collaboration (and actioning) easy and seamless. Additionally, since it is built on the Salesforce platform, the Chatter feature can be used to power real-time collaboration and communication.
Having a well-designed audit management process makes sure quality leaders “know their gaps”. With CQ’s Audit Management Software, we ensure enterprises have the ability to build a scalable and configurable audit management workflow. Depending on the specific needs of your company, you can automate a rapid audit process or configure a workflow for a complex audit.
The CQ Audit Management Software enables easy access to documents and reports of past audits, in addition to capturing failure trends and triggering corrective or preventive action for continuous improvement. This is a key requirement for Total Quality Management in the pharma industry.
CQ Training Management allows you to train employees in a timely fashion and keep your workforce skilled and job-ready.
Integrating training into your EQMS supports a stable, reliable, and repeatable training management process, ensuring that your entire organization has the knowledge it needs, from GxP guidelines to international standards to government regulations. CQ Training Management tackles this challenge by helping businesses manage all personnel, job functions, requirements by job functions, courses, and documents to be trained on. For TQM efforts, it may be a good idea to include training content on the importance of bringing in a quality-first mindset to any activity.
World-class quality teams rely on real-time data to make decisions. With a modern EQMS like ComplianceQuest, which serves as a single source of truth for all key quality data, capturing insights from data becomes easier. With the right dashboards, charts, and the Quality Control Tower, the implementation of TQM becomes more meaningful and data-driven.
To know more about how ComplianceQuest EQMS can help automate TQM processes in your pharma or biotech company, request a demo here:https://www.compliancequest.com/online-demo/
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