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Middle Office Platform
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
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
Safety 2025 Conference & Expo
22 Jul, 2025
Orlando, FL
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.
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
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The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
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Stronger Together: How our partnerships drive success and innovation
Upcoming Events
The demand for advanced therapy medicinal products (ATMPs) is growing fast due to their ability to deliver personalized treatment addressing the root cause rather than treating symptoms. Thanks to the transformative advantage it provides, not offered by conventional treatments, the overall market size for ATMPs is expected to touch USD 21.2 billion by 2028, delivering a 13.2% CAGR for the next seven years.
This has led to several academic institutions and start-ups initiating research and development for cell and gene therapies (CGT). However, CGT manufacturing is a complex process requiring adherence to Good Manufacturing Practice (GMP) and periodic regulatory audits to ensure compliance.
Right from cell collection to the delivery of the therapy, each step involves several processes that bring their own risks and require controls.
For a manufacturer to ensure that each of these processes adheres to the cGMP requirements, auditing becomes crucial. A robust audit process is critical to delivering customer satisfaction, mitigating risks, reducing failure, and increasing operational efficiency.
Audits can be of two types – internal and external. Treating internal audits with as much seriousness will prepare the CGT companies for external audits. The feedback generated during the audit can help with driving continuous improvements in service standards, thereby enhancing product quality and customer satisfaction.
Some of the benefits of audits include:
By improving the outcome of audits, comply with regulatory standards such as:
Create an auditing checklist to facilitate a systematic audit of the manufacturing facility covering the following:
Prepare: This is an essential first step to improve the outcome of the audit.
Facilities: The auditors tour the facility to review:
The auditors should be accompanied by an employee who is aware of the complete process and can answer accurately any queries they may have.
Personnel: A review of the team members including:
Supply Chain: Review of
Quality Assurance (QA):
Quality Control (QC):
Outsourcing Control:
Documentation:
For businesses that understand the value of auditing, want to automate and manage the audit lifecycle better, the Audit Management Software from ComplianceQuest is ideal. From scheduling audits to managing the entire audit lifecycle, it allows visibility and traceability through its features such as:
Planning and Scheduling Audits: Automate your audit workflow by planning your internal and external audits at a predetermined frequency based on business risk and relevant regulatory requirements. Plan and schedule, document findings and initiate CAPA as required. Calendar views can be set up in the system to alert all stakeholders of scheduled audits and enable them to prepare accordingly. Choose between complex, stringent, or streamlined audits.
Effective Continuous Improvement: The audit management software provides data at their fingertips, enabling businesses to identify gaps and forecast quality performance. Ready access to documents and reports of past audits helps to understand past failure trends and initiate CAPA for continuous improvement, leading to improved performance, customer delight, and thereby, revenue growth.
Stay Compliant: Be compliant with applicable regulatory standards covering different aspects of the product value chain.
Remain Audit and Inspection Ready: A proactive risk management strategy enables businesses to be 100% compliant by identifying gaps, planning, and managing changes, learning from past audits, creating schedules and assigning roles and responsibilities, organizing data and documents, and conducting periodic internal audits. The CQ Audit Management Software provides visibility and transparency at every step of the auditing process.
The pandemic compelled the regulatory bodies to allow remote audits. To find out more about how ComplianceQuest facilitates remote audits, check out:
https://www.compliancequest.com/blog/quality-safety-leaders-audit/https://www.compliancequest.com/blog/blueprint-for-effective-efficient-remote-audit-process/
Request a demo: https://www.compliancequest.com/online-demo/
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