_leader_enterprise_leader.png?sfvrsn=b46555cc_1)
_bestrelationship_enterprise_total.png?sfvrsn=b96555cc_1)
_leader_europe_leader.png?sfvrsn=826555cc_1)
_momentumleader_leader.png?sfvrsn=576555cc_1)
Digital Document Management
Your documents should be digitized and available anytime, anywhere. MasterControl's QMS utilizes cloud architecture and a secure system to digitally vault and manage documents.
Over 500+ 5-Star Reviews
Can QMS Software Help You Avoid Common FDA Compliance Missteps?
Prevent FDA Form 483 observations and warning letters with purpose-built QMS software
Take a close look at your quality management systems and software. Do your current systems and processes help you stay FDA compliant and avoid the common pitfalls that can lead to Form 483 observations and warning letters? Learn what to watch out for and how the right quality management solutions can further enable FDA compliance and aid in noncompliance mitigation.
- Discover the most common reasons for FDA Form 483 observations and warning letters and how to avoid them.
- See what you can do right now to address ineffective quality compliance systems.
- Find out how implementing QMS software like MasterControl’s quality management solutions can help you easily maintain FDA compliance.
_leader_leader.png?sfvrsn=916555cc_1)
Awarded #1 Quality Management System in the Life Sciences
Loading Content
Trusted By 1,100+ Companies Worldwide
Recent G2 Awards
Item 1 of 8
Dive into a world where compliance, efficiency, and quality converge seamlessly
- Organize documents automatically
- Collaborate on documents virtually
- Automatically launch training tasks
- Securely share documents outside of your organization
- Remain audit-ready and 21 CFR Part 11 compliant
Change Control
Take control of change control with tools that help you handle policies, work instructions, engineering change, and more.
- Digital signature and approval workflows
Change control, revisions, versioning, and automatic archiving
Automatic training tasks when documents change
Audit trail for regulatory compliance
Training and Exams
MasterControl's training management software greatly improves your employee training program. It automates all training tasks, from routing and tracking to follow-up and escalation.
- Automatic routing, tracking and follow-up
- Connected documents and automated processes
- Audit-ready records
- Maintain and prove regulatory compliance
Quality Events and CAPA
MasterControl puts you in control of quality events. Our latest advanced quality event management solution literally puts the power to design, build, and automate processes - as well as analyze quality event data - in the hands of quality professionals.
- Use our best-practice templates or create your own custom processes - no coding needed.
- Simplify complex processes and bring logic to quality events.
- Increase efficiency with email notifications, in-app notifications, and actionable tasks lists.
Compliance and Audit Management
Add tools to your processes that make it easier to plan and prepare for internal and external audits.
- Schedule audits with drag-and-drop calendaring
- Guest Connect streamlines auditor feedback
- Connected platform for sharing documents and launching events
- Create reusable audit templates and standards
Risk Management
Get your products out the door successfully and avoid added costs with tools that help you assess and manage risks.
- Visibility into risk-related activities
- Configure and evaluate multiple risk types
- Tracking and analysis for identifying and mitigating risks
- Launch assessments within the MasterControl system
Data Analytics and Insights
Get the most out of all the critical information produced by your QMS by turning that data into actionable business intelligence.
- Capture and structure data effortlessly
- Configure and evaluate multiple risk types
- Easily create customized, interactive dashboards
- Explore smart insights (AI-powered automatic insight generation)
FDA Compliance Simplified with MasterControl
Life sciences companies competing in the demanding FDA regulatory environment know how important attaining and sustaining compliance is to annual success. This can be easily achieved through MasterControl's FDA compliance software solutions. As a leading provider of FDA compliance software, MasterControl has helped hundreds of life science companies around the world realize their FDA compliance goals.
-
1,100 +
Customers
-
850 K
Users
-
30
Years Serving Life Sciences Companies
-
43
G2 Awards for Summer 2024
-
36
Countries with MasterControl Customers
Learn More about MasterControl's QMS Software
Item 1 of 3
MasterControl's Quality Management System
Ensures compliance, lowers risk, accelerates timelines, and improves speed and quality while reducing costs. Don't just keep up with the industry—lead it confidently into the future.
Ready to revolutionize your Life Sciences operations?
Take the first step by signing up for a demo. Your journey to unparalleled excellence starts here!
