Case Studies

We are passionate about the potential of software as a tool to solve critical business problems. However, we understand that our success lies far beyond delivering great software. We are only successful when our customers' projects are successful.

In the following success stories, learn how MasterControl helped these organizations overcome stringent quality and regulatory challenges.

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To recieve PDF documents of the case studies, click on the checkbox next to the companies you're interested in, then click on the submit button at the bottom of the page.

	ARUP Laboratories 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." Go to Submit Button
	Aplicare 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." Go to Submit Button
	Iowa Blood 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." Go to Submit Button
	Weider Nutrition 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." Go to Submit Button
	Namsa 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." Go to Submit Button
	Stay InFront 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." Go to Submit Button
	Teva Pharmaceutical 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." Go to Submit Button
	Asymtek 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." Go to Submit Button
	Mallinckrodt Baker 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.” Go to Submit Button
	Sorenson Medical 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.” Go to Submit Button
	Hu-Friedy 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 supporting our implementation and for the most part, things went extremely well." Go to Submit Button
	Syncardia Systems Inc. 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!" Go to Submit Button

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