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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
Pricing
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
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
Interphex
01 Apr, 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 product, quality, safety, and supplier as they bring their products from concept to customer success.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
Transform your approach to Quality and Compliance with our software, designed to optimize processes, ensure regulatory excellence, and drive operational success.
In the ever-evolving landscape of business operations, the significance of quality and compliance software cannot be overstated. It helps businesses navigate the stringent regulatory frameworks while upholding uncompromising standards by:
Introduction Corrective and Preventive Actions (CAPA) are integral to maintaining compliance and quality in various industries, particularly in the highly…
Just recently, the CQ Product and Marketing teams participated in a brainstorming session at a conference for healthcare, medical device,…
Any organization has a variety of tasks to be performed by various departments. These functions intersect at various points and…
Quality and compliance management software addresses the complex challenges of maintaining high standards and meeting regulatory requirements while streamlining quality assurance, ensuring adherence to industry standards, and managing compliance across various sectors.
While enabling the establishment and maintenance of robust quality management systems (QMS), the software enables organizations to:
The quality and compliance management software provides a central repository for regulatory requirements, allowing businesses to navigate and stay up-to-date with evolving compliance mandates. It assists in monitoring regulatory changes, ensuring that companies remain compliant, and minimizing non-conformity risks, such as financial penalties or reputational damage.
This software typically offers features such as:
By leveraging data-driven decision-making, organizations can proactively address issues, optimize processes, and continuously enhance their products or services.
It acts as a strategic enabler for businesses, fostering operational excellence, ensuring regulatory adherence, mitigating risks, and ultimately contributing to sustained growth and competitiveness in today's dynamic business environment.
Quality and compliance management fundamental for organizations across industries to operate efficiently, sustainably, and competitively. These practices ensure adherence to regulations, guarantee product/service excellence, mitigate risks, and foster continual improvement, positioning businesses for long-term success in today's demanding and competitive marketplace. They enable:
Meeting Regulatory Requirements
Various industries are subject to stringent regulations and standards imposed by governmental bodies or industry authorities. Compliance ensures adherence to these mandates, preventing legal issues, fines, or operational interruptions.
Ensuring Product/Service Quality
Quality management aims to consistently maintain high standards in products or services. Meeting and exceeding customer expectations regarding reliability, performance, and safety fosters loyalty and a positive brand reputation.
Risk Mitigation
Non-compliance and poor quality pose significant risks to organizations, such as legal liabilities, financial losses, and reputational damage. Effective management helps identify and mitigate risks associated with deviations from standards or regulations.
Enhancing Efficiency and Productivity
Implementing standardized processes through quality management streamlines operations, minimizes errors, and boosts productivity. It optimizes workflows, reducing waste and ensuring effective utilization of resources.
Continuous Improvement
Quality and compliance management frameworks, such as Six Sigma or ISO standards, promote a culture of continuous improvement. By collecting and analyzing data, businesses can identify areas for enhancement and implement corrective actions.
Customer Satisfaction
High-quality products or services and regulation adherence translate to increased customer satisfaction. Meeting or exceeding quality expectations builds trust, leading to repeat business and positive referrals.
Competitive Edge
Maintaining quality standards and compliance provides a competitive advantage. It distinguishes firms in the market, attracting customers who prioritize quality and reliability.
Compliance, Security, and Trust—Our Core Commitment
ComplianceQuest is ISO 9001, ISO 27001, and SOC 2 certified, ensuring that your data is protected under global security standards.
Seamless Implementation, 24/7 Expert Support
Implementing a new QMS shouldn’t disrupt your operations. With ComplianceQuest, enjoy a hassle-free deployment process supported by industry experts.
Tailored Solutions for Your Industry
Every industry faces unique quality and compliance challenges. ComplianceQuest adapts to your regulatory framework, operational structure, and business goals.
Why Choose ComplianceQuest Over Others?
With so many QMS solutions available, how do you decide? ComplianceQuest outshines competitors like MasterControl, Veeva, ETQ, and Intelex with:
Key Differentiators
Different regulatory bodies impose varying requirements for quality and compliance management across industries, reflecting diverse standards and expectations. Here are some examples of regulatory bodies and their respective quality and compliance management requirements:
Each regulatory body outlines specific standards and guidelines tailored to its industry. Compliance necessitates meticulous documentation, stringent quality control measures, regular audits, and proactive risk management strategies. Understanding and adhering to these diverse requirements is crucial for businesses to operate legally, sustainably, and competitively within their respective sectors.
Quality and compliance management software offers several features designed to streamline processes, ensure adherence to standards, and facilitate regulatory compliance. Some key features include:
These features collectively empower organizations to establish and maintain robust quality management systems, ensuring compliance with regulations, enhancing operational efficiency, and fostering a culture of continuous improvement.
Customer Success
Compliance with the European Medical Device Regulation (MDR) necessitates an effective Quality Management System (QMS) aligned with its stringent standards. To adhere to EU MDR, organizations involved in the medical device industry must establish and maintain a comprehensive QMS. This system should encompass robust documentation, risk management protocols, clinical evaluation, post-market surveillance, supplier management, and stringent quality control measures. Adherence to EU MDR's QMS requirements ensures the safety, efficacy, and quality of medical devices marketed within the European Union, promoting patient safety and regulatory compliance.
I’ve been using ComplianceQuest (CQ) for about 9 months and am extremely pleased with the product, the implementation team and ongoing support.
I selected CQ for a number of reasons. Functionality and a simple user interface were key requirements. CQ has all the functionality needed in support of a global QMS. Implementation includes; Document control, change order, personnel training, NC/CAPA, equipment management, supplier management, audit management, and customer complaints all on a single platform. As a small biologics company it was critical to find a single solution to meet our GMP quality system requirements. We wanted a cloud-based system, that would be quick to implement, that could be expanded globally and in other languages, all for a reasonable price. The user interface – it is exactly what I was hoping for. I constantly hear the staff saying, “I love CQ, it’s so straightforward to use”.
Donna Matuizek,Sr. Director Quality
A successful strategy for EU Medical Device Regulation (MDR) compliance involves a phased approach:
Evaluate current processes, identify gaps, and understand the new MDR requirements.
Update QMS documentation, align processes with MDR standards, and establish clear roles and responsibilities.
Train staff on new procedures, implementing and managing changes and ensure seamless integration into operations.
Validate updated processes, conduct internal audits, and address findings to ensure conformity with MDR.
Continuously monitor performance, gather feedback, and improve the QMS to maintain compliance and enhance efficiency.
Comprehensive MDSAP Quality Management Assessment: 4 Key Audit Checklists for Medical Device Companies
Checklist | April 3rd, 2023
MDSAP Quality Management System (QMS) Assessment Checklist (Part 1): Scope, Leadership, Commitment and More
Checklist | April 6th, 2022
MDSAP Quality Management System (QMS) Assessment Checklist (Part 2): Planning, Support, Operations and More
MDSAP Quality Management System (QMS) Assessment Checklist (Part 3): Analysis and Evaluation, Management Review and More
MDSAP Quality Management System (QMS) Assessment Checklist (Part 4): Nonconformity, Corrective Actions and More
Noncompliance with IVDR QMS requirements poses significant risks. It can lead to legal penalties, market withdrawal of products, reputational damage, and loss of market access. Additionally, noncompliance may compromise patient safety and trust in the affected medical devices.
The In Vitro Diagnostic Regulation (IVDR) and the U.S. Food and Drug Administration (FDA) Quality Management System (QMS) requirements share similarities but have notable differences:
Regulatory Scope: IVDR focuses specifically on in vitro diagnostic medical devices within the European Union (EU), while FDA QMS requirements apply to medical devices marketed in the United States.
Risk Classification: IVDR adopts a risk-based classification system for IVDs, emphasizing higher scrutiny for higher-risk devices. FDA's approach to device classification is broader, covering various types of medical devices.
Clinical Evidence: IVDR necessitates comprehensive clinical evidence for all classes of IVDs, including performance evaluations. FDA also requires clinical data but may have different requirements depending on the device classification.
Post-Market Surveillance (PMS): IVDR significantly emphasizes post-market surveillance, requiring continuous monitoring and reporting. FDA also requires post-market surveillance but may have different reporting timelines and mechanisms.
Documentation Requirements: IVDR and FDA QMS have stringent documentation requirements, but specific documentation formats and content may differ between the two regulatory bodies.
Labeling and Traceability: IVDR and FDA mandate clear and comprehensive labeling; however, specific details and requirements regarding labeling and traceability might vary.
While both IVDR and FDA QMS aim to ensure the safety and efficacy of medical devices, differences exist in their regulatory approaches, classifications, and specific requirements, reflecting the distinct regulatory landscapes of the EU and the United States. Companies operating in both markets need to navigate and comply with these differing regulations for market access.
The medical device sector is highly regulated worldwide due to the direct impact these products have on patient health and…
Digital transformation involves many things. It requires all documents to…
The Food and Drug Administration1 (21CFR 820.30) defines Design Controls…
Complaints! Although we may be focused on quality, any product…
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