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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
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
FDA training is necessary to remain compliant. It keeps employees abreast of the current regulations and guidance and helps them adhere to them. The FDA training program includes various subjects — from conducting inspections to responding to 483s or warning letters.
Food and Drug Administration (FDA) is the U.S. Federal agency that protects public health by regulating a range of products, including food, pharmaceutical drugs, cosmetics, dietary supplements, medical devices, vaccines, electromagnetic radiation emitting devices (ERED), blood transfusions, and veterinary products.
Additionally, the FDA is also responsible for regulating the manufacturing and selling of tobacco products. Non-compliance with FDA regulations results in penalties on a company for regulatory violations that affect customer confidence in its safety and efficacy.
FDA training helps create awareness about the regulatory requirements. The FDA regulatory training also prepares employees to handle any situation with potential risks. FDA-regulated industries are challenged with numerous regulations and FDA training for compliance is essential to:
At ComplianceQuest, our training management solution is integrated with our EQMS and EHS Solutions. It is designed to drive continuous…
Regulatory authorities such as the FDA (and standards like ISO) require organizations to maintain specific standards across quality processes. Quality…
According to FDA 21 CFR Part 820.70(i), any software used to automate any part of the device production process or…
FDA developed various training materials, including webinars, courses, and other materials to understand better the FDA’s regulation of product safety, quality, and efficacy.
The regulatory training helps regulators, foreign and domestic industry, medical professionals, academics and others to remain FDA compliant.
Some of the focus areas include:
The requirements for regulatory training focused on GMP are divided into two aspects — the types of employees who need to be trained and the components of the training program.
FDA is very specific about who is trained and what they are trained for. Some of the guidelines for the FDA training include:
The FDA training program is overseen by the senior management. To meet FDA requirements, manufacturers must prepare and conduct detailed training programs that will sustain the quality of the products and the safety of the employees.
The FDA regulatory training plan must include all the training information, such as CSR regulation and other job function-specific procedures. An FDA inspection includes an evaluation of the training documents. FDA regulatory training program will focus on:
Customer Success
Following the FDA software validation guidelines, CQ assists customers throughout the process of validating the entire solution. Once the solution is installed, CQ will help with the following:
Ensures that the solution is installed correctly.
Establishes documented evidence that operating characteristics perform within the limits and specifications defined for the system.
Allows conversion of the OQ to PQ to establish documented evidence of consistent performance as defined for the system.
Provides design and test traceability.
ComplianceQuest also supports 21 CFR Part 11 FDA compliance requirements for life sciences organizations in health care, pharmaceutical, life science, biotechnology, medical- manufacturing, medical devices, and other FDA-regulated industries. This also allows companies to adopt a ‘paperless’ system of record keeping. Our solutions include:
Electronic Signature:
As required by 21 CFR Part 11, ComplianceQuest ensures that the user has signed onto the system and automatically secures the authenticated user’s electronic signature. Every time a transaction is processed, signed authentication is mandated making it a secure process similar to a paper-based system.
Audit Trail:
ComplianceQuest system has an Audit Trail that securely and automatically posts all field changes to a separate database, including the details of the user who made the change, date and time. This stored audit trail information can be queried and accessed at the time of any regulatory audit.
We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.
Helen Cary,Document Control Specialist
New Employee Training Checklist – After an Employee Starts
Checklist | December 14th, 2022
New Employee Training Checklist – Before an Employee Starts
Bloodborne Pathogens Exposure Control Audit Checklist (Part – D): Policies and Specific Training for the Hepatitis B Vaccine and Policies for Specific Labelling
Checklist | June 30th, 2022
Bloodborne Pathogens Exposure Control Audit Checklist (Part – B): Employee Training
FDA 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to that of the paper records. It is applicable to all in the life sciences industries including Medical Devices manufacturers, drug makers, biologics developers, and biotech companies. 21 CFR Part 11 stipulates the guidelines and rules for storage, copying, access & permissions, audit logs and tracking.
Part 11 applies to drug makers, biotech companies, medical device manufacturers, CROs, biologics developers, and other FDA-regulated industries, with some specific exceptions. The code is for implementing controls such as audits, audit trails, electronic signatures, system validations, and documentation for software and systems.
The COVID-19 pandemic was an eye-opener. Despite all the advancements…
You would be surprised to know that many of the…
Earlier this year, the Food and Drug Administration (FDA) decided…
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