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Solutions Solutions WHAT WE OFFER 01 Quality 02 Manufacturing 03 Clinical 04 Regulatory 05 Supplier 06 Product Development 07 Postmarket Quality Solution Overview Document Control Change Control Training Management CAPA Software Deviations Management Nonconformance Out of Specification Audit Management Quality Management Risk Management Spark QMS for Small Business Manufacturing Solution Overview Batch Records Device History Records Equipment Calibration ERP Software SystemMRP Software SystemManufacturing Resource PlanningProduction Operations ManagementRecipe Management System Clinical Solution Overview Clinical Management Trial Master File Trial Software Laboratory QMSAudit SoftwareTMF Checklist Regulatory Solution Overview Regulatory Information Management (RIM) Submissions for 510(K) and PMA Submissions for eCTDSubmissions Management510K Guidance CTD File Supplier Solution Overview Supplier Management Bill of Materials Supplier Management Audits Vendor Management Supplier ScorecardSCAR Supplier Deviation Development Solution Overview Design Control Change Control Software Change Management Software Change Order Change Management Tool Postmarket Solution Overview Customer Complaints Medical Device Reporting (eMDR) Complaint Tracking System Complaint Example Device Reporting Software Platform Everything you need to know about what makes MasterControl the right solution for you. See More Pricing Take a look at our pricing plans and request an estimate that works for your business. See More Resources Resources COMPLIANCE CENTER 01 FDA 21 CFR 02 ISO 03 Global Regulations 04 Platform Integrations 21 CFR Part 11 21 CFR Part 111 21 CFR Part 1270—1271 21 CFR Part 210—211 21 CFR Part 606 21 CFR Part 820 ISO 9000 ISO 9001 ISO 13485 ISO 14000 ISO 14971 ISO 15189 ISO 17025 TS 16949 CLIA Canadian Standards EU Annex 11 EU Medical Device Regulation ERP Software System MRP Software System MES System Manufacturing Resource Planning Production Operations Management LIMS System LEARNING CENTER White Papers Content Library Blog - GxP Lifeline SUCCESS CENTER Case Studies Success Plans WHAT WE OFFER 01 Our Company 02 Events 03 Become a Partner Why MasterControl Our Core ValuesExecutive Team MasterControl In The News Upcoming Events Masters Summit North America Masters Conference Europe Masters Forum Asia Let’s do Lunch Partner Program Referral Partners Sales Partners Service Partners Technology and Strategic Partners JOIN OUR TEAM Careers Giving Back BECOME A PARTNER Partner Program Industry Associations Login UK English / United States English / United Kingdom Deutsch / Deutschland Français / France 日本語 / 日本 English / Australia Contact Us Dx Development Make Quality by Design effortless with MasterControl Development Excellence™. Learn More About Development Cx Clinical Manage clinical trial files from beginning to end with MasterControl Clinical Excellence™. Learn More About Clinical Rx Regulatory Clear regulatory hurdles and get to market faster with MasterControl Regulatory Excellence™. Learn More About Regulatory Qx Quality Changes Everything Digitize, automate and accelerate quality to transform your business with MasterControl Quality Excellence™. Learn More About Quality Sx Supplier Increase visibility and ensure compliance throughout your supply chain with MasterControl Supplier Excellence™. Learn More About Supplier Mx Manufacturing Eliminate the tradeoffs between line performance and product quality with MasterControl Manufacturing Excellence™. Learn More About Manufacturing Px Postmarket Manage in-market complaints and close your quality loop with MasterControl Postmarket Excellence™. Learn More About Postmarket Our Platform Development Dx Clinical Cx Regulatory Rx Quality Qx Supplier Sx Manufacturing Mx Postmarket Px Learn more about our business continuity plan in response to COVID-19. Learn More The platform for quality. Explore how the MasterControl Platform™ digitizes, automates and connects quality and compliance across your entire product life cycle. Learn More About Our Platform Life changing results from real companies. Play It’s a competitive advantage. See how Wellington Foods is using MasterControl Manufacturing Excellence™ to eliminate paper on the shop floor and ensure great quality products. Watch Now PlayQuality is a mindset you need from the very beginning. Learn how BraveHeart is using MasterControl Spark™ to embed quality into design and to get their product to market. Watch Now View All Case Studies The War On Paper: A Corrective Action Plan for Going Paperless After all, digital transformation initiatives often feel overly ambitious, poorly defined and years away from having meaningful impact. So why disrupt the status quo? Why invest in going all-in on digital? Learn More Architecting For Change: Embracing a Platform Approach Embracing digital is now so instinctive, you would digitize and automate everything. You would invest in cloud-based technology that was easy to use, connect and scale. Learn More The Human Side of Automation: Putting People at the Center of Process Automation Are our automated tools merely machines that complement and simplify our work, or will they ultimately make us obsolete? Learn why humans and their ability to solve problems and interpret information will always be the core component of any automation initiative. Learn More View More Resources Let’s chat Sales +44 (0)800 138 3534 Corporate +44 (0) 1256 325 949 Contact Us Solutions Quality Manufacturing Clinical Regulatory Supplier Product Development Post Market Learning Center Learning Center Success Plans White Papers Case StudiesAbout MasterControl MissionUpcoming Events Partner Program Careers6350 South 3000 East Salt Lake City, Utah 84121 View map Cookie Notice Privacy Policy Terms & ConditionsLegal© MasterControl, Inc. All rights reserved....