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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
Product development takes effort and time. Compliant design development requires extensive documentation that can affect productivity, leading to delivery delays or non-compliance. Every minor change must be tracked as it can lead to a series of changes, tests, reviews, validations, and verifications. Teams using spreadsheets or disparate systems find it difficult to document these changes. Having a design project management helps improve visibility and traceability and supports high-quality design products that meet regulatory and quality standards.
Design Project Management is a comprehensive development process that accounts for every part, design requirement, design input, user need, and product risk during the design lifecycle. With design project management, manufacturers can have end-to-end control over the design aspects of any project. With design project management, the project manager can define the project’s goals, assign and track tasks across teams, maintain focus, and organize everyday tasks to achieve the goals. Design project management helps:
Design project management helps:
The Food and Drug Administration1 (21CFR 820.30) defines Design Controls as: “A set/framework of quality practices and procedures incorporated into…
We’re excited to announce the launch of the cloud-based Product Design Management Solution from ComplianceQuest. We believe that it’s a…
Building new products and services can be a process filled with uncertainty. However, following the systematic new product development process…
Product design in manufacturing companies involves various stakeholders that need to work together to create an end product. This includes understanding customer requirements, evaluating raw materials, product designing, product testing, and compliance check. The end-to-end process of product design can be long and tedious. Having a manual system can be laborious and time-consuming as all parties involved cannot work together at the same time. A robust, cloud-based Product Design Management Solution, on the other hand, can help manufacturers across industries to:
Create efficient design processes that reduce development time, minimize scrap, and rework
Implement changes and updates faster without missing delivery timelines
Reduce human errors in the documentation that can directly impact approvals and entry into market
Improve the quality of products by addressing all expectations, requirements, and risks
Host all product and design-related data in one centralized location for everyone to access, thus creating visibility and coordination
Minimize development costs while reducing the development cycle, thus increasing profits
A robust Product Design Management software makes collaboration easier, offering design teams better control over design inputs, requirements, and risks to improve product quality while ensuring compliant documentation. CQ’s Product Design Management Solution includes various components such as:
Some of the features of of CQ’s Product Design Management Solution include:
Businesses are moving towards cloud-based product design management solutions as paper-based systems became tedious to maintain and affected compliance. Manufacturers in the medical device industry are constantly looking for solutions that can interact with other systems in the organization and minimize the efforts of collaboration. While selecting a product design management solution for the business, it is important to look at the various features the solution offers, including its ability to
ComplianceQuest Product Design Management is one of the leading solutions in the market for its ability to show results. The solution can
Our organization approached ComplianceQuest to help implement Aphira Inc.’s first ever Electronic Quality Management System. With a very tight project timeline, ComplianceQuest was able to execute and hit all milestones on schedule that has increased our company’s Quality procedures two fold. What impressed me the most was the unparalleled customer service! The employees go above and beyond to ensure your projects success is their top priority, while also learning your company’s internal processes to provide potential solutions/enhancements. ComplianceQuest (CQ) has set the bar high and I would strongly recommend them to any organization looking for a state of the art QMS.
Jake NickelsAphria Inc (now Tilray)
Performing design and development activities manually is labour intensive, error-prone, and has a high chance of rework. It can increase the cost, cause wastage of limited resources, delay the commercialization process, and contribute to loss of business. Globally, the primary objective of all manufacturers (irrespective of the risk class of medical devices) is to ensure the product is safe and effective. The foundation for this is rooted at the “design stage” of product development, so safety and efficacy have to be built in. When implementing design project management, it is important to:
Understand the user’s needs as it is the foundational step to success. Gather every piece of information to understand what customers want to improve chances of approval.
Determine the specific requirement of the product by classifying the collected information into different categories.
Create goals and budgets for team members based on expectations. Document these in the Requirement Traceability Matrix for checking.
Define the design process to ensure there is consistency. This includes specifying tools and various communication channels that will be used to update the design process.
Assign tasks to every team based on their expertise to avoid confusion and waste of time.
Test, review and validate product design to avoid reworks.
Design feedback and approval are critical to understand if the product meets the requirements and expectations of the client it set out to fulfil.
Medical device manufacturers must get compliance approval before pushing the product to the market.
A Comprehensive Design History Files Checklist
Checklist | August 17th, 2022
Are My Design and Development Changes Documented Adequately – Let’s Check!
Is Your Design Transfer Activity Complete?
Essential Design and Development Review and Approval Criteria
Verification and Validation During Product Design and Development
Complying with the Regulatory Requirements During Design and Development Stages
From a regulatory perspective, ‘design control’ or ‘design and development’ is a mandatory requirement for any regulatory authority while reviewing for market approval/authorization. To ensure the product is developed safely considering all the necessary stages, there should be adequate and relevant evidence so as to assure the same was reviewed, approved, verified and validated before moving into commercial production and distribution.
CQ Product Design Development allowing all departments involved in the design process to collaborate effectively and remain in-sync. With the solution, engineering, quality, regulatory, suppliers, regulatory, and manufacturing teams can work together without siloes.
Inefficient processes leads to longer development time, slows the ability to implement changes, affects delivery timeline, and increase cost due to scrap, waste, and rework.
Increased risk of non-compliance due to improper change management, human error due to manual processes, missed approvals in documentation process, and delays in entry to market.
Lower quality products due to inability to identify, track, and manage product related risks.
Less product innovation as there is scattered product data.
Increased development costs due to low design quality and missed profits.
A good product design will have:
Utility value that meets customer expectations and delivers steady performance throughout the product lifecycle
Economic value that adds to the sales and profit of the organization
Different from its competitors in terms of features and marketing
Producible using available production methods
Aesthetically appealing to the end customer and larger market
Having a clear vision for the product design at the beginning of the project helps all the stakeholders by creating a course of action that can be followed end-to-end. From a quality performance perspective, design project management helps in three different ways. They are:
Quality issues are easier to fix at the design stage rather than rework after manufacturing. This saves on production cost and redesign time.
Having a quality policy document in place right from design phase will give all key stakeholders clarity on what is expected in terms of quality performance.
Overall Cost of Quality (CoQ) reduces when the right design control process is adopted and reduces the chance of product failure.
Are product quality issues slowing down your innovation and growth? Many organizations struggle with costly recalls, delays, and compliance risks,…
In today’s fast-paced manufacturing landscape, product lifecycle management (PLM) is…
The journey to manufacturing a product is filled with several…
In an effort to continuously improve the quality and safety…
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