Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
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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
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
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
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
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
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
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]
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
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
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.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
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.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
As the regulatory environment gets more and more stringent for regulated industries such as medical devices, pharmaceutical, and life sciences, we hear of even leading brands being penalized on various counts – deceptive marketing, violation of books, records and internal accounting controls, off-label or unapproved promotion of medical products, Controlled Substances Act violation, consumer protection violation and so on.
In the pharmaceutical industry alone, total penalties from compliance-related violations have crossed over US $50 billion since 2000. The numbers are not too far behind in other regulated industries as well.
According to a report by research firm Ponemon Institute and security company GlobalScape, the annual cost of non-compliance in a single company was anywhere between $2.2 million and $39.2 million and has increased by 45% since 2011. The cost of compliance, on the other hand, had increased by 43% and was an average of $5.5 million.
But as more companies, migrate from legacy systems to modern, cloud-based compliance management tools and technologies, the average cost of compliance will come down. A next-generation, cloud-based platform like ComplianceQuest, for example, offers the breadth and depth of features, while also ensuring scalability, flexibility, and cost-effectiveness.
Fines are not the only cost of non-compliance. FDA, for instance, may take recourse to any of the following actions based on the severity of the non-compliance:
In a recent guidance, the FDA declared penalties of up to $10,000 per violation for flouters of the ClinicalTrials.gov reporting requirements or those submitting false or misleading information to the database, in which case there would be civil injunction and/or criminal prosecution as well. An additional $10,000 would be levied till the violation is corrected. Violators’ notices of non-compliance will be posted on the FDA website as well as CT.gov.
These actions can prove costly with market erosion, damage to reputation, and loss of customer trust, which are hard to win back. Litigation and compensations are additional costs that businesses will have to pay, which can severely drain financial resources.
Compliance may seem like a cost center. It involves a range of systems and processes to be put in place to ensure high-levels of compliance:
However, over the years, a well-implemented compliance management system results in benefits such as:
With every different aspect of a business being governed by rules and regulations, compliance can become challenging if done manually. Software such as the Enterprise-wide Quality Management Solution from ComplianceQuest is built on the scalable and cloud-based Salesforce.com and aligns with all the major regulations that a business needs to comply with. It provides enterprise-wide visibility of processes and data. ComplianceQuest is designed to not only ensure aligning with the regulations but also enhance the quality of the products and services, improve risk management. The ComplianceQuest QHSE (EQMS + EHS) also serves as a single source of truth for all key regulatory, compliance, quality, safety, health, and environment management data. It serves not only as a system of record but as a system of collaboration, making it really easy for compliance leaders to work together to meet regulatory requirements.
To find out how to reduce your cost of non-compliance, contact us here. https://www.compliancequest.com/contact-us
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