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.
U.S. Food and Drug Administration (FDA) inspections are commonly followed by a list of objectionable conditions and compliance violations, listed in a Form 483 or warning letter. When it comes to medical device and other life sciences manufacturing, the same problems routinely top FDA 483 lists — problems involving quality responsibilities and procedures.
A complete, end-to-end QMS that digitizes and integrates all quality processes will help FDA-regulated manufacturers reduce the risk of Form 483 observations and warning letters. A digitally connected EQMS unifies document control, quality events, change control, training, customer complaints, audit management, and much more.
Awarded #1 Quality Management System in the Life Sciences
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.
Take control of change control with tools that help you handle policies, work instructions, engineering change, and more.
Change control, revisions, versioning, and automatic archiving
Automatic training tasks when documents change
Audit trail for regulatory compliance
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.
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.
Add tools to your processes that make it easier to plan and prepare for internal and external audits.
Get your products out the door successfully and avoid added costs with tools that help you assess and manage risks.
Get the most out of all the critical information produced by your QMS by turning that data into actionable business intelligence.
FDA inspections can be stressful, and findings cited in a Form 483 list can have significant consequences depending on a manufacturer’s response, including warning letters, consent decrees, or worse. FDA-regulated companies must maintain a robust EQMS to help reduce the risk and impact of compliance infractions.
With nearly three decades of experience in the rigorous FDA environments, MasterControl has developed a complete EQMS that combines industry best practices with an integrated suite of tools that improves quality processes and associated documentation. It provides all the tools needed to be audit-ready and reduce the risk of Form 483s and warning letters.
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.
Take the first step by signing up for a demo. Your journey to unparalleled excellence starts here!