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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
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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
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Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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ComplianceQuest Medical Devices QMS Success Stories eBook
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Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
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Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
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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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Upcoming Events
Key Highlights:
The Eight Disciplines of Problem-solving (8D), first introduced by Ford Motor Company in the 1980s as Team Oriented Problem Solving (TOPS), is an effective framework for finding solutions. It helps in identifying the root cause of any problem, implementing a short-term fix, and also creating a long-term solution to prevent a recurrence.
While it is extremely popular in the automotive and manufacturing industries, 8D has become a preferred method for problem-solving for quality engineers and other professionals across segments such as healthcare, retail, finance, government, and manufacturing.
The 8D methodology helps identify, correct, and eliminate recurring problems, making it useful for both product and process improvements.
The 8D problem solving model uses statistical analysis to identify root causes and identify a corrective action/preventive action. It begins with D0, which is the planning stage, and then proceeds to:
In the 1980s and 1990s, the 8D process could be conducted manually due to less complexity in processes. But today, globalization has led to the outsourcing of the manufacturing process with a globally spread out supply chain.
Challenge #1 – The 8D team could be drawn from members spread across different geographies. To bring product and process experts to one location can disrupt work and lead to loss of productivity, not to mention the associated costs. It is key to running an 8D process with the right tools and data at your fingertips. The digital tool used must enable ease of collaboration, documentation and brainstorming.
Challenge #2 – The interdependence of processes requires greater visibility into the impact of a change upstream and downstream. For instance, a change introduced in one process will affect a process downstream or may require some changes to be made upstream for the required change to be effective. Therefore, verifying this manually can be limiting and prone to errors.
Challenge #3 – Maintaining effective communication between the participants as well as with the rest of the organization is crucial for the successful implementation of findings after 8D analysis. With people working in different time zones and with different priorities, making sure all are aligned to the new requirements can become difficult.
Challenge #4 – Documentation of the CAPA process is a regulatory requirement. However, in a manual 8D approach, documentation can be complicated, incomplete, and updating and maintaining it can be time-consuming and costly.
While 8D stresses on verification of corrective actions before implementation, FDA and ISO regulations governing CAPA, require manufacturers to demonstrate the efficiency of CAPA after it was implemented.
Points 3 and 4 of 21 CFR 820.100, for instance, states that the CAPA actions implemented for nonconformance and other quality problems need to be verified or validated to ensure their effectiveness and that they do not adversely affect the finished device.
ISO 13485:2016 – 8.5.2 Corrective action also lays down
This requires data to be collected over a period of time, depending on the volume of production, and then it is analyzed for its effectiveness and conformance.
CAPA effectiveness check has to be based on key performance indicators and requires:
The cloud-based EQMS from ComplianceQuest is designed to align your processes with industry standards and regulations such as ISO and FDA. Our CAPA Solution, is tailored for problem-solving and intuitively integrates the 8D approach to problem solving and effectively manage your Corrective And Preventive Action (CAPA) processes and drive Continuous Improvement (CI).
The CQ solution facilitates collaboration between experts located in remote locations, enables easy communication/brainstorming, and captures discussions and findings into documents and records that can be shared within the group as well as the rest of the organization, as needed.
With CQ CAPA Management Software, you can do root cause analysis, detect trends, conduct or link to an existing investigation and root cause analysis, define action plans to change or improve, and ensure effectiveness checks with a structured verification and closure.The solution integrates with enterprise-wide systems such as ERP and CRM to provide a holistic view of processes across the lifecycle and access to real-time data for effective monitoring and tracking. The EQMS also offers a Change Management solution to manage changes and ensure performance.
The foundation blocks and a built-in workflow indicator of the CAPA solution from ComplianceQuest facilitate the adoption of various problem-solving approaches such as the 8D model, World Class Manufacturing (WCM), and 5W2H.
One of the key elements is the Effectiveness Verification and Closure feature that tracks the effectiveness of the CAPA action and closure of CAPA once it is proven.
Here’s what Lia Budiman of Continental Contitech said about using ComplianceQuest to automate various quality and compliance processes:
“Great product, support, and people to work with!
We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With the integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.
CQ configuration team and support have worked hard to ensure that our needs continue to be met. They consistently go above and beyond. We cannot be more pleased with our use of CQ QMS capabilities and would definitely recommend to anyone who is looking for a modern cloud-based EQMS solution especially if you want a scalable EQMS solution.”
To know more about how you can leverage ComplianceQuest’s CAPA Management Solution for your 8D problem-solving needs, request a demo here: https://www.compliancequest.com/online-demo/
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