Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
Discover your potential savings with our ROI Calculator
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
Medical Device & Manufacturing East
20 May, 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 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 ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
For any clinical trial, the following requirements have become mandatory from a data and documentation standpoint:
To facilitate the evaluation of the conduct of a clinical trial, CROs need to put together an Electronic Trial Master File (eTMF) that accurately captures the activities that will be performed during the course of the trial and the key decisions taken related to the trial.
This is also required by the EU Commission Directive 2005/28/EC 63 Chapter 4 Article 16 and FDA’s CFR 21 Part 11.
These documents also need to be audit-ready and easily accessible for inspection by regulatory authorities. The inability to provide comprehensive TMF has often been identified as a major problem during clinical trials.
Looking for a modern eTMF to collaborate better and be prepared for an FDA inspection anytime? At ComplianceQuest, we offer a modern, cloud-based eTMF solution. Request a demo here: https://www.compliancequest.com/online-demo
In this blog, we highlight why ComplianceQuest’s eTMF is an ideal solution for CROs and sponsors.
Compliance: Due to the number of documents involved, manual management of the TMF can be very time-consuming and prone to errors. By digitalizing the process, CROs and sponsors can benefit from real-time visibility into all eTMF artifact activities and integrate with other quality and compliance-critical functions.
The CQ eTMF solution provides a view of what is required, what is completed, and what is missing in the eTMF at all times. The application of the DIA TMF Reference Model helps automate the entire lifecycle of eTMF and alleviates administrative burdens through features such as:
This helps improve compliance as well as provides improved visibility into trial compliance gaps that can be converted into corrective and preventative actions.
Reports and Dashboard: Reports and dashboards provide stakeholders with insights into critical metrics such as timeliness, quality, missing approvals, expiring documents, and completeness of eTMF. The study team and management can assess the health of all clinical documents and the gaps identified to align site/study management for improved compliance.
Collaboration: One of the greatest advantages of the CQ eTMF solution is that it facilitates collaboration, exchange, and tracking of information from within a single system. Providing secure and direct access to the documents enables instant viewing and sharing of data, records, and documents by the clinical study team.
It also makes it easy to assign, create, collaborate, review, and approve all TMF artifacts with better efficiency. Users are alerted when a particular item needs their attention. The Chatter function allows study teams to brainstorm changes to artifacts in real time and have access to everything that was discussed.
Organized Storage: Unlike in a file server, the eTMF covers end-to-end strategies, methods, and tools used through the lifecycle, and is organized such that core documents are collated together and site-related documents are bundled into a section. With appropriate naming and access control, retrieving documents with proper authentication becomes easy.
Easy Searchability: CQ eTMF solution supports full-text search of documents, metadata, and attachments to find and review critical trial information faster. Study teams can spend less time searching and more time managing the eTMF process. In addition, you can easily generate reports from any data collected in the system.
Ensures Business Continuity: Being a cloud-based solution, the CQ eTMF can be accessed from anywhere, anytime, and on any device, ensuring business continuity and clinical efficiency, visibility, and flexibility.
Improved Trial Visibility: By providing a unified view of all trial-related data, records, and documents, the CQ eTMF solution improves visibility and flexibility. This can help prevent potential major non-compliance events through on-time adverse event reporting and timely interventions.
Integrated with a next-generation EQMS: Over and above these benefits is the fact that CQ eTMF is integrated with ComplianceQuest’s EQMS solution. This plays a key role in integrating quality-related processes into the clinical workflow. For instance, if you find an issue in the eTMF, it is not easy to trigger a CAPA and plan the next steps to fix the problem at hand.
To know more about the CQ eTMF solution and how it can improve eTMF document management efficiency, quality, and risk management
Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive Demo Video.
Please confirm your details
By submitting this form you agree that we can store and process your personal data as per our Privacy Statement. We will never sell your personal information to any third party.
In June 2021, McKinsey published an article on the decentralization of clinical trials. The report…
The 2016 International Council for Harmonization (ICH) E6 (R2) Addendum to the Good Clinical Practice Guideline recommends…
The regulations governing medical device and in vitro device manufacturing industries are aimed at improving…