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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
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
Self-guided Product Tours
Product Demo Videos
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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.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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Recent Infographics
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Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
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Complaint Handling Process for MedTech and Life Science Companies
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Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
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Unlocking the Value of Complaints
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Whitepaper
Why You Need to Digitally Transform Your QMS
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Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
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Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
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Featured Event
American Society on Quality World Conference on Quality and Improvement
04 May, 2025
Denver, CO
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 product, quality, safety, and supplier as they bring their products from concept to customer success.
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Jen, the VP of Quality Assurance at one of the world’s largest medical device manufacturing companies based in Minneapolis, MN, was preparing for her bi-monthly Management Review Meeting (MRM). It was a freezing day in December, with the city completely buried in snow. The quality leader got off a quick call with the CEO’s executive assistant and they decided to do the meeting virtually.
The VP of Quality logged in to the company’s EQMS system and downloaded various reports and data charts. She was all set, thanks to having access to a modern, cloud-based EQMS solution.
Overall, the company was doing very well in terms of quality except in the case of one new product. After some quick number crunching, Jen realized that the biggest reason for quality issues in this problematic business unit was repeated internal failure. There were issues in both the lab and the shop floor. And, unfortunately, these issues weren’t caught before they went out the door and resulted in customer complaints.
Here’s a replay of the conversation between Jen and the CEO during the MRM.
CEO: I am glad we’re doing very well across most of our business units. The quality metrics in our cardiovascular portfolio are top-notch. Can we get to the same level in our neuromodulation products?
Jen: Thanks, Bob. (Getting straight to the point) I knew this would come up and I’ve done an RCA of why we’re seeing so many customer complaints in the neuro product. The biggest problem is internal. We should actually catch most of these issues even before it leaves our facilities.
CEO: What do we need to make it happen?
Jen: I am working on a more robust nonconformance management system. A few processes are completely new in this business unit, and our QMS needs a little tweak. We need a slightly modified, customized workflow that includes a deeper understanding of internal failure.
CEO: Go on…
Jen: I am setting up a “mock customer” within our facilities, one who would test out our neuromodulation batches for key quality metrics. We conducted a 5 Why and there are three major reasons for failure: a) equipment issues in the lab. We need to upgrade and maintain this better, so our calibration is as good as our customers’. b) better training for our people. c) spot process variations ahead of time.
CEO: The last one is critical. We cannot afford to have any process variations. Equipment and training-related aspects seem like low-hanging issues that can be tackled. Right?
Jen: Absolutely. I am automating the entire nonconformance management process. I will keep you in the loop.
Over the next three months, Jen was completely focused on driving a complete digital transformation of the nonconformance workflow. Here’s what she had to do.
At the core of catching nonconformance issues is having access to data. It requires a deep understanding of what the customer is looking for and retooling the QMS to ensure these quality requirements are met before it leaves the proverbial four walls of the company.
When the lab or shopfloor team spots issues, they take corrective action (and preventive action) as needed. But, often, the process of retesting after the change is not robust enough. Tweaking the nonconformance management process to do this will be a game-changer.
With a modern, next-generation nonconformance management system, one can automate the workflow to ensure that adequate notifications and prompts are sent out so that the following actions are taken by the team as part of the change process :
At the medical device company we described above, it was difficult to spot trends and patterns from past nonconformance data. They didn’t have the right platform to look for past data as a whole, run analytics and draw insights.
With a solution like ComplianceQuest Nonconformance Management Software, it is easy to:
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