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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
American Society on Quality World Conference on Quality and Improvement
04 May, 2025
Denver, CO
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 product, quality, safety, and supplier 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
cGMP (Current Good Manufacturing Practices)
cGMP stands for Current Good Manufacturing Practices. It is established by the U.S. Food and Drug Administration (FDA). cGMP is a set of quality assurance guidelines and regulations that ensure the safety, quality, and consistency of pharmaceutical, biotechnology, and food products. cGMP must be followed by manufacturers throughout the production process, from the design of facilities and equipment to the testing, storage, and distribution of products.
Complying with cGMP is essential for regulatory compliance and delivering safe, effective, and reliable products.
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The FDA ensures that the quality of drugs manufactured at the facility is in compliance with cGMP regulation. cGMP compliance includes the implementation of modern quality systems and a robust risk approach that meets the 21 CFR part 210 and 211 of cGMP regulations. The primary goal is to encourage the adoption of modern manufacturing technologies. For cGMP compliance implementation, the manufacturer must focus on the following steps:
Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA that assure systems have the proper design, monitoring, and control of manufacturing processes and facilities. FDA assessors and investigators determine if a firm has the necessary equipment, facilities, and ability to manufacture the drug to sell in the market. By adhering to the CGMP compliance regulations, a manufacturer assures the identity, strength, quality, and purity of drug products through controlled manufacturing operations.
To remain cGMP compliant, organizations must incorporate a Quality Management System. A robust QMS helps improve quality within the organization. To meet many of cGMP compliance and regulatory requirements, follow these steps:
Ensure data is complete with controls
Document activities at the time of performance
Assign ownership of activities to a specific individual
Authorize only individuals to make changes to the recordsa
Establish a record to identify a change in data
Review records for accuracy, completeness, and compliance with established standards
Maintain data security right from data creation through disposition after the record’s retention period
Adhering to cGMP compliance regulations focuses on:
Customer Success
To implement a functioning and compliant quality system that supports cGMP regulations, the company’s management must focus on the following parameters:
ComplianceQuest pairs the user-friendly tools of SalesForce with a very capable and responsive development / support team resulting in a full QMS application that was adapted to our processes and very easy to implement. Our large, global organization is not an easy group to please. From their patient participation in our configuration workshops to their quick responses to every email and crazy request, the CQ team has proven to be a true partner in our implementation. Their website and demos show how user-friendly and well integrated the modules are. The REAL win is getting this functionality with a team who is truly invested and has gone over and above to make our implementation a success!
Melanie Lees,Quality Director
There is a significant overlap between QMS and cGMP regulations. As both emphasize product quality and documentation of processes, implementing a QMS helps with cGMP compliance in several ways. Some of them listed below:
Analyze data for trends to help identify and resolve problems, and prevent mishaps
Evaluate the effectiveness of implementation and maintenance of quality systems through periodic internal audits
Understand the various elements of risk for effective decision-making process through quality risk management
Prepare corrective action by addressing the root cause to prevent the recurrence of significant problems
Create succession planning, training, institutional knowledge, plans for changes as part of preventive actions
Effective and efficient use of a robust QMS promotes improvement
Pharmaceutical CGMP Regulations with Quality System Part 1
Checklist | July 27th, 2021
Pharmaceutical CGMP Regulations with Quality System Part 2
Checklist | July 29th, 2021
Pharmaceutical CGMP Regulations with Quality System Part 3
Checklist | August 5th, 2021
CGMP for Finished Pharmaceuticals – Control of Components and Drug Product
Checklist | November 29th, 2021
Quality system and CGMP compliance regulations training should focus on both the employees’ specific job functions and the related CGMP regulatory requirements. While cGMP training is important, managers must determine the training program’s relevance to the employee’s role in the organization. Simply put, managers must focus on training programs that include the following:
Evaluation of training needs
Provision of training to satisfy these needs
Evaluation of the effectiveness of training
Documentation of training and/or re-training
While FDA does not mandate the frequency of cGMP training, it is essential to conduct the training at regular intervals of time instead of one massive session. The training must be conducted periodically based on employee availability, the time needed to conduct the training, type of training, whether class or online, and the establishment or removal of processes. Continuous cGMP compliance training is essential to:
Ensure that employees remain proficient both in their operational functions and in their understanding of CGMP regulations.
Address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior).
Gain skills that can be implemented in the day-to-day performance.
CQ’s Training Management solution allows organizations to create and manage training programs and to quickly allocate content to the many job functions an employee may be assigned. By combining training content with developed assessments, the solution ensures that not only employees get trained but also verifies their comprehension. As part of the EQMS solution from ComplianceQuest, the training solution helps:
Identify training gaps, missed deadlines, and overdue training so employees can remain in compliance and properly skilled as requirements change.
Define training plans specific to particular job roles/titles to ensure position-specific functionality and compliance.
Gain a complete view of training compliance with your documents connected to training programs and data that is stored and easily retrieved from one place.
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In today's rapidly evolving workplace, effective Environmental Health and Safety…
Transit authorities function in a strictly regulated environment where adherence…
At ComplianceQuest, we recently published a whitepaper titled ‘Safety Intelligent Analytics:…
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