Join ConQuest 2025 | ComplianceQuest User Conference | April 8–10, Clearwater Beach, FL
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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
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
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
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
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
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
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]
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
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
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.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
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.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
The global Covid-19 pandemic compelled the United States to lock down and implement social distancing. Putting the safety of its own employees first and meeting federal guidelines to mitigate the spread of the COVID-19 virus, the U.S. Food and Drug Administration (US FDA) only conducted mission-critical inspections and paused all other domestic and foreign inspections. For routine surveillance inspectional activities, it implemented several innovative approaches by leveraging available digital tools.
Knowing the critical nature of its function, the FDA adopted several approaches for inspections during the pandemic. It conducted remote inspections and published a guidance document on how to run remote interactive evaluations using live-streaming of drug manufacturing facilities. It also developed a COVID-19 Advisory Rating system (COVID-19 Advisory Level) to qualitatively assess the virus risk at the county level and identify sites where it was safe to conduct an inspection.
The FDA also utilized section 704(a)(4) that assigns FDA the authority to request records and other information from domestic and foreign establishments for:
By accessing compliance history reviews of facilities, recalls and product complaints, it was able to prioritize oversight activities.
It leveraged the information shared by trusted regulatory partners at the state, local, tribal, and territorial levels. Under the Mutual Recognition Agreement (MRA), it was able to leverage information provided by trusted foreign regulatory partners.
Risk-based product sampling and analytical testing of FDA-regulated products domestically and at international borders also helped with confirming compliance.
Despite these efforts, the FDA has been unable to complete inspecting all the facilities for which it received applications. Of the nearly 21,000 establishments it regulates across all commodities including human and animal drugs, medical devices, radiological health facilities, biologics, biological research monitoring, and tobacco, it was able to complete only 13,000.
Now the agency says it plans to conduct a total of 26,250 surveillance inspections in FY21, including any remaining surveillance inspections postponed from the previous fiscal year. As of March 2021, the agency had inspected 2,953 of these facilities.
It has released a "Resiliency Roadmap for FDA Inspectional Oversight" for providing transparency into its plans for the future while giving an overview of the past year. This roadmap lists out its plans for base/best/worst-case scenarios as the pandemic continues to spread around the globe.
The FDA will be using a risk-based approach to speed up the inspection work without compromising the safety of its workforce.
The best-case scenario envisages resuming normal inspection operations. In the base-case or average scenario, it will resume normal operations after mid-summer. In the worst-case scenario, it will continue with its restrictive pandemic operations.
There are three types of inspections that the FDA conducts:
For-cause Inspections: conducted when there is a serious manufacturing problem or in case of a specific problem or product complaint that has been brought to FDA’s notice
Pre-approval, Pre-market or Pre-license Inspections: when an application to market a new product is submitted, the inspection conducted as part of the review when necessary
Surveillance: routine inspections of regulated facilities to monitor ongoing compliance with requirements such as Current Good Manufacturing Practice (CGMP)
But because of the pandemic, it restricted itself to mission-critical inspections that are prioritized and include:
The FDA conducted 822 mission-critical inspections in 2020-21.
The past year and the pandemic have provided the FDA with an opportunity to consider more efficient regulatory approaches to fulfill its public health mission of ensuring product quality. To this end, it plans to advance regulatory convergence and explore collaborative approaches with trusted partners as well as foster alignment around modernizing policies and practices for improving its outcomes.
It plans to expand its workforce to meet its goals better and step-up modernization efforts to transform its data enterprise platforms and cross-program interoperability infrastructure for enabling innovative approaches to regulatory oversight.
Some of the key modernization efforts will include investing in next-generation assessment technologies and improvements while reviewing available authorities for potential legislative proposals.
To speed up evaluation and potential integration of new oversight methods and tools, the FDA will also work on improving coordination for inspections, information sharing, and other processes. As a result of consistent use of tools and technologies, it expects to increase flexibility and further encourage a data-driven, risk-based oversight modeling across the agency as well as the nation’s public health system.
Mission-critical and prioritized inspections will continue to be the focus areas for FDA throughout the pandemic and routine surveillance of facilities with less risk will be a lower priority, but additional tools will be deployed to continue the protection of public health through regulatory oversight.
Through this roadmap, FDA has reiterated its commitment to public health and patient safety.
For life sciences, pharma, and medical device companies equally committed to patient safety and quality of their products, ComplianceQuest provides a next-generation QHSE solution to automate end-to-end quality and safety management. Improve internal processes, enhance product quality, drive up operational excellence and meet compliance to reduce the burden on FDA to conduct for-cause inspections with ComplianceQuest.
To know more about ComplianceQuest’s EQMS and EHS, check our recent whitepaper titled "Top 12 Reasons Why Your Enterprise Needs a QHSE Built on the Salesforce Platform".
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