Controlled corporate-wide SOPs, CAPAs, and other quality processes
Facilitated training when documents changed due to corrective actions
Ensured compliance with 21 CFR Part 11
Quote: "When searching for a quality management solution, we found that MasterControl met all our needs including the necessary elements to comply with 21 CFR Part 11 for electronic records and signatures."
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Computerized paper-based document control processes for SOPs, flowcharts, and floor plans
Helped company expand business without additional quality overhead
Sustained GMP 21 CFR Part 606 Part 11 compliance
Quote: "We produce products that will in one form or another be transfused to patients. It is paramount that we have current procedures and job aides available for our staff to follow at all locations at all times. This is what our customers expect and this is what the FDA expects. MasterControl allowed us to do this better and more efficiently than possible with our previous paper-based processes."
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Replaced dual hybrid system with an integrated electronic QMS
Electronic system streamlined quality processes and made compliance with numerous regulations and international standards (FDA, EU GMP, OECD, ICH E6) easier to manage
More efficient document review and approval system using compliant e-signature features
Quote: "Our system [MasterControl] has helped me especially in streamlining the review and approval process of QS documents and providing me a superb tool for assessing the compliance state of Actelion."
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Automated document change control
Validated system in less than 2 months
Ensured compliance with QSR 21 CFR Part 820
Quote: "MasterControl's tools allowed us to complete the validation process quickly and proved a crucial component to meeting our November deadline."
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Automated paper-based quality system for Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
Successfully migrated 2,000 documents, SOPs, stability profiles, product information, and technical reports from MasterControl Client/Server system into the new Web-based MasterControl suite
Were able to globalize company quality management system by connecting the separate systems of different plants
Quote: "The auditors gave very favorable comments about our MasterControl system. They noticed that everything was easily traceable, documents were readily available, and electronic signatures were all there."
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Dramatically cut the time to modify and approve SOPs
Helped sustain compliance with GMP 21 CFR Parts 210-211
Provided electronic access to over 3500 procedures
Quote: "MasterControl really stood apart from the other companies in the area of cost compared to value. Its capabilities matched 89 percent of our requirements, and the comprehensive cost estimate was significantly lower than the other proposals."
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Helped ensure compliance with FDA’s 21 CFR Part 820, Quality System Regulation (QSR), and ISO 13485 :2003
Dropped cycle time from about four weeks to one
Departments using MasterControl include Marketing, Customer Service, Accounting, Engineering, Document
Control, Quality, Regulatory Affairs, IT, Employee Services, Technical Service, Purchasing, Production, and Production Planning
Quote: "MasterControl personnel were always genuinely interested in
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Dramatically improved efficiency
Automated paper-based quality management system
Helped connect QA, research, development, testing, customer service, and HR departments to the enterprise quality system
Quote: "We're actually changing more documents and doing more work now, precisely because we're more efficient and capable of doing more."
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Helped ensure compliance with 21 CFR Part 11 and 21 CFR Part 820
Provided a single repository for all documentation
Helped optimize the company’s quality processes, making compliance easier
Quote: "We picked MasterControl because of its compliancy features. Strict compliance was our main goal."
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Simplified document change process
Enabled consistent compliance with 21 CFR Part 11
Accelerated revision cycle
Quote: "There's no way we could have gotten this far without MasterControl. This is the third company I've been with that had MasterControl and I understand the value of the system and how remarkable it is. …We now use MasterControl to the max!"
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Migrated entire client/server quality system to the Web-based MasterControl
Electronically manage over 36,000 CAD, forms, work instructions, etc.
Helped sustain and improve ISO 9000 compliance capabilities
Quote: "Hard copy documents are no longer needed by manufacturing to assemble products. Now everyone can access assembly documents from online with MasterControl."
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Helped sustain compliance with GMP 21 CFR Parts 210-211
Connected departments company-wide to quality system
Improved collaboration between employees and departments
Quote: "Today, about 200 employees across the organization use MasterControl, including those belonging to the infrastructure and development teams, quality services, client services, help desk, human resources, sales and marketing, and accounting departments."
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Improved time-to-market
Changed approval times from months to just a few days
Helped ensure GMP compliance with 21 CFR Part 11 and 211
Quote: "Being the first to market with an innovative product is crucial
in our industry and MasterControl is the key to making this happen."
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