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
21 CFR Part 11 Compliance Checklist – Key Things to Know
A guide to how a company can submit documentation in an electronic form and the criteria for approved electronic signatures set by FDA
FDA’s 21 CFR Part 11 is a regulatory framework guiding companies on creating and managing digital records and signatures. Facilitating regulatory oversight is the core focus of 21 CFR Part 11, while the driving force is to ease the cost and burden of maintaining paper records to satisfy regulators.
In regulated industries such as life sciences and medical devices, the value of a world-class document management solution cannot be…
In June 2021, McKinsey published an article on the decentralization of clinical trials. The report highlighted the following trends: Key…
The demand for advanced therapy medicinal products (ATMPs) is growing fast due to their ability to deliver personalized treatment addressing…
FDA 21 CFR Part 11 matters for the following reasons:
Security controls for user identification:
21 CFR Part 11 compliant systems must have security features that limit user access and their privileges based on roles and responsibilities to prevent unauthorized system access.
Detailed audit trail:
For an audit trail, you must use the software that is capable of keeping a daily record of all functions initiated by the user or the software.
Electronic signatures:
21 CFR Part 11 compliant systems can assign unique electronic signatures to each user and are legally binding.
The objective of the regulation is to streamline compliance and allow businesses to speed up their operations with electronic records management systems and signatures. These compliance guidelines are especially important when implementing a software solution that is designed to facilitate 21 CFR Part 11 compliance.
Here are some of the benefits of 21 CFR Part 11 compliance including:
Better operational efficiency
Low expenses
Enhanced system security
In-built efficient employee training
Huge savings on storage space
Simplified patent filing
21 CFR Part 11 compliance checklist and requirements can be broken down into six key requirements that must be met for compliance.
Validation
21 CFR Part 11 requires that all elements of the system are working and develop the scripts and testing routines to validate that it is functioning. Validating the EQMS ensures data security and audit logs as well as increases the integrity of record keeping.
Record generation
21 CFR Part 11 specifies that the EQMS should have a search and indexing functionality so that records can be found quickly and easily. A good EQMS solution can have all document changes and iterations, as well as display the digital signatures of any approval.
Audit Trails
arrow-rightAudit Trails A good QA function associated with audit history ensures that the development of all processes is well documented and traceable to a specific originator. This audit history should be automatically generated.
Operational Controls
A sophisticated EQMS will allow for quality procedures to be monitored and ensure that documents are reviewed by specified individuals and that they meet certain requirements before they are signed off and the contingency phase begins.
Security Controls
Access to a system should be controlled by a unique login and password for every user. EQMS can determine the number of people who can alter certain documents, track each version of the file, as well as identify those who have altered it in the past. Final records should be read-only.
Digital Signatures
A good EQMS will give administrators complete visibility and control over the use of signatures across the systems. They can create and cancel signature requests along with setting the locations where signatures can be used to protect against fraud.
Training
21 CFR Part 11 stresses that all system users should have the essential training to perform their assigned tasks and projects. An EQMS can itself assist with these requirements by accepting conditions upon signing in to the system or by documenting this responsibility as part of training.
Customer Success
Using a checklist for evaluating a system's compliance with 21 CFR Part 11 helps companies demonstrate to regulators that their system meets the necessary standards. This checklist serves as a comprehensive tool that assists businesses in navigating the complexities of regulatory requirements and ensuring compliance. It also aids in enhancing processes and verifying that the organization has implemented appropriate systems and procedures. By using a 21 CFR Part 11 compliance checklist, businesses can identify potential areas of risk and take necessary measures to mitigate them. To effectively track compliance with the regulation, the following elements are essential to include in the checklist:
Assess whether 21 CFR Part 11 applies to your company
Follow 21 CFR Part 11 data security and password protection best practices
Establish clear audit trails for traceability
Follow 21 CFR Part 11 guidelines on electronic signatures
Validate For IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification)
Consider 21 CFR Part 11 compliance when choosing a QMS solution.
Consider 21 CFR Part 11 compliance when choosing a QMS Solution.
21 CFR Part 11 applies to all electronic records or signatures that are maintained, created, or processed under any records requirements as defined by the FDA. Any records that are stored, signed, or processed digitally for biotech, life science, or other FDA regulated companies fall under the regulation.
It primarily applies to businesses operating in the US in the biotech, life science, medical instrumentation, or similar industries. Many non-food businesses that are within the jurisdiction of the FDA must meet 21 CFR Part 11 compliance. In the present times, it is difficult to maintain a fully-paper record, so almost all businesses in these sectors are affected.
As a Life-Sciences manufacturing services startup in Costa Rica, our company decided early on that a flexible, agile QMS was a must. We had a very clear set of requirements: cloud-based, cross-platform, mobile-enabled, paperless, e-signature capable.
After reviewing available solutions against these, only CQ met our needs. Right after the demo, we knew we had a winner. The implementation process was relatively smooth and our solution engineer was top notch. We went live a couple of months ago and recently aced through our first customer external audit.
If you are searching for a modern, flexible and powerful QMS solution for a forward-looking company, look no further: CQ is your answer. As a Life-Sciences manufacturing services startup in Costa Rica, our company decided early on that a flexible, agile QMS was a must. We had a very clear set of requirements: cloud-based, cross-platform, mobile-enabled, paperless, e-signature capable. After reviewing available solutions against these, only CQ met our needs. Right after the demo, we knew we had a winner. The implementation process was relatively smooth and our solution engineer was top notch. We went live a couple of months ago and recently aced through our first customer external audit. If you are searching for a modern, flexible and powerful QMS solution for a forward-looking company, look no further: CQ is your answer.
Bernal Rodríguez,CEO
ComplianceQuest (CQ) enables 21 CFR Part 11 FDA compliance for life sciences organizations such as healthcare, pharmaceutical, biotechnology, medical manufacturing, medical devices, and other FDA-regulated industries. It facilitates implementing controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing many forms of data, business practices and product development. 21 CFR Part 11 executes the FDA’s requirement to recognize electronic records and electronic signatures as trustworthy, reliable, and legal equivalents to paper records and handwritten signatures. This also allows companies to adopt a ’paperless’ system of record keeping.
FDA 21 CFR Part 11 – Electronic Records Validation, Integrity And Compliance
Checklist | May 18th, 2021
Supplier’s Change Notification or Changes in Critical Raw Material: Medical Device Manufacturer Impact Evaluation Template
Checklist | November 16th, 2021
Compression Area Safety Audit Checklist for Pharmaceutical Companies
Checklist | May 26th, 2022
Warehouse Area Safety Audit Checklist for Pharmaceutical Companies (Part – B): Wash Area, Primary and Secondary Packing Material Store, Bonded Storeroom, and More
The requirements of 21 CFR Part 11 not only ensure the integrity, authenticity, and confidentiality of raw electronic data, but also the non-repudiation of electronic signatures. It’s the researcher’s responsibility for demonstrating that the instruments and software used to collect and analyze data are validated to meet the 21 CFR 11.
As organizations grow and expand across geographies, compliance becomes increasingly complex. Whether you’re overseeing quality in a global biotech company…
Quality Manuals and SOPs have grown bloated over time—some stretching…
In 2018, the US FDA had announced its plans to…
Laboratory-Developed Tests (LDTs) were initially governed by the Medical Device…
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.