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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
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
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Featured CQ Guide
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Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
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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
MEDevice Silicon
19 Nov, 2025
Silicon Valley, CA
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
Newsroom
The Pulse of ComplianceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
Centralize your laboratory operations with ComplianceQuest Lab Management Software, the ultimate laboratory management software for life sciences and pharmaceutical labs. Our platform automates workflows, ensures regulatory compliance, and provides real-time insights for smarter, audit-ready labs.
Unlike traditional systems, lab management software from ComplianceQuest seamlessly integrates with existing Laboratory Information Management System (LIMS software) solutions, helping labs maximize data visibility, efficiency, and compliance without replacing their current LIMS setup.
Lab Management Software (LMS) is the backbone of modern laboratory operations. It ensures accurate data management, seamless workflow execution, and compliance with strict regulatory requirements. While a Laboratory Information Management System focuses primarily on sample tracking, a comprehensive laboratory management software solution like ComplianceQuest goes beyond by integrating investigations, documentation, training, and regulatory readiness.
In life sciences and pharmaceutical labs, delays or errors in sample handling, investigations, or reporting can compromise operational efficiency and regulatory compliance. By adopting lab management software, organizations can transition from reactive problem-solving to proactive risk prevention.
Key Benefits Include
ComplianceQuest provides a feature-rich laboratory management software platform designed to simplify and modernize lab operations while ensuring compliance with regulatory standards:
Lab Investigations (OOS Automation): Automates Out-of-Specification investigations, reducing errors and accelerating root cause analysis.
Sample & Workflow Management: Tracks the lifecycle of each sample from receipt to disposal, ensuring full traceability. Integration with LIMS software enhances sample data visibility and workflow coordination.
Equipment & Inventory Management: Monitors instruments, calibrations, and consumables with automated alerts to avoid shortages and maintain compliance.
Document & Training Management: Digitizes SOPs, protocols, and training records, keeping lab teams audit-ready.
AI-powered Insights (CQ.AI): Predictive analytics identify recurring issues, forecast failures, and provide actionable recommendations.
Regulatory Compliance: Aligns with GLP, GMP, GCP, FDA 21 CFR Part 11, and ISO certifications.
These capabilities provide a single, connected platform for managing people, processes, and technology in the lab, making ComplianceQuest a strategic enabler of lab excellence.
Proper complaint management is critical for detecting and resolving product or service shortcomings. Complaint management is also a compliance requirement…
In drug manufacturing quality control, a robust, well-defined testing and lab investigation process is critical to ensure that the drug…
ComplianceQuest Lab Management Software integrates seamlessly with traditional Laboratory Information Management System software (LIMS software), adding value through:
This allows labs to act on data intelligently rather than just tracking it.
Beyond LIMS, lab management software integrates with ERP, MES, CRM, and HRMS systems to create closed-loop quality processes. This allows:
By centralizing lab and enterprise data, ComplianceQuest:
Compliance is non-negotiable, especially in life sciences and pharma. ComplianceQuest simplifies compliance by embedding frameworks into lab workflows.
Regulatory Alignment
ISO Standards Support
Inspection-Ready Labs
Outcome
ComplianceQuest reduces compliance burdens, builds regulator trust, and safeguards patient and consumer safety.
Modern labs generate vast data—but without proper tools, insights are lost. ComplianceQuest, powered by CQ.AI, unlocks predictive insights and intelligent automation.
Capabilities
Impact
ComplianceQuest helps labs evolve from reactive management to proactive leadership, driving compliance, safety, and efficiency.
Effective lab operations depend on precise management of samples, instruments, and consumables. ComplianceQuest provides end-to-end control, ensuring accuracy, traceability, and efficiency across the lab.
Key Benefits of Integration
By integrating sample, equipment, and inventory management, ComplianceQuest:
Customer Success
Investing in ComplianceQuest delivers measurable returns that extend far beyond cost savings.
Audit-Ready Compliance and Centralized Data
Enhanced Team Collaboration
AI-Driven Efficiency and Predictive Insights
Cloud Scalability for Multi-Site Labs
Future-Ready Laboratory Management Software
Clear ROI
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”.
The implementation team has met all my expectations. The CQ product ‘out of the box’ meets the majority of my requirements. With some minor configurations we have developed QMS workflows that are highly efficient and robust. A risk-based validation plan also allowed us to move quickly through the foundational functions; Controlled Documents, Change Order, and Personnel. The implementation team offer many industry best practices as solutions to questions and are also highly competent in listening to your requirements and doing whatever is necessary to fulfill them. Customer Support is incredibly timely in their responsiveness; addressing most questions or concerns within 24-48 hours, meanwhile communicating along the way. We are extremely happy with our selection and highly recommend ComplianceQuest.
Donna Matuizek,Sr. Director Quality
Identification & Assessment of Out-Of-Specification (OOS) Test Results – Laboratory Investigation checklist
Checklist | July 12th, 2022
A checklist on Full scale OOS Investigation – Production (Part A)
A Checklist on Full-scale OOS Investigation – Retesting & Resampling (Part B)
A Checklist on Full scale OOS Investigation – Reporting Test Results
A Checklist to Conclude OOS Investigation
A Step-by-Step Guide For Risk Management In Clinical Investigation Process, Medical Devices
Checklist | November 16th, 2021
ComplianceQuest automates the entire OOS workflow, linking investigations to CAPA and quality management processes. Root cause analysis tools guide teams through structured steps. Integration with LIMS software ensures faster resolution and regulatory compliance with FDA 21 CFR Part 11 and GLP.
While not a LIMS, ComplianceQuest integrates seamlessly with Laboratory Information Management System software. It enhances LIMS data with quality workflows, predictive insights, and enterprise integration, turning data into actionable intelligence.
Powered by CQ.AI, ComplianceQuest predicts failures, detects recurring issues, and sends proactive alerts. Integration with LIMS data ensures optimized sample handling, faster turnaround, and improved compliance.
Yes. It provides version-controlled documentation, automated reporting, secure electronic signatures, and audit-ready workflows. Labs can leverage Laboratory Information Management System software integration to streamline inspection preparation.
Absolutely. Its cloud-native architecture enables global collaboration, centralized data visibility, and consistent compliance standards across multiple labs.
Section 21 CFR 211 of Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals includes detailed requirements for OOS investigations: 211.84…
In 2021, 5,190 workers suffered fatal injuries and 2.6 million…
OOS and OOT investigations are an essential part of clinical…
What is a Safety Investigation? A safety investigation is a…
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