Études de cas
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.
Actelion Pharmaceuticals Ltd.
- 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
"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." – Actelion Pharmaceuticals Ltd.
- Automated document change control
- Validated system in less than 2 months
- Ensured compliance with QSR 21 CFR Part 820
"MasterControl's tools allowed us to complete the validation process quickly and proved a crucial component to meeting our November deadline." – Aplicare
- 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
"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." – Mallinckrodt Baker
- 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
"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."
– Teva Pharmaceutical
- 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
"MasterControl personnel were always genuinely interested in supporting our implementation and for the most part, things went extremely well." – Hu-Friedy
- 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
"We're actually changing more documents and doing more work now, precisely because we're more efficient and capable of doing more." – Namsa
- 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
"We picked MasterControl because of its compliancy features. Strict compliance was our main goal." – Sorenson Medical
Syncardia Systems Inc.
- Simplified document change process
- Enabled consistent compliance with 21 CFR Part 11
- Accelerated revision cycle
"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!"
– Syncardia Systems Inc.
Gift of Life Michigan (GOLM)
- Switched to MasterControl primarily for FDA compliance
- Developed a proactive education training program that facilitated user acceptance
- Within two weeks of going live, 90 percent of users were trained on new system
"We're clinically oriented so we wanted a user-friendly system. It really helped that MasterControl is user-friendly."
– Gift of Life Michigan (GOLM)
- Automated document control and training for large-scale organ procurement efforts
- First time conducting validation, which was a critical part of implementation
- Recommended having MasterControl consultant onsite to assist with validation
"It's a very unique task that really took my understanding of quality and regulatory affairs to a new level." –LifeCenter Northwest
MD Anderson Cancer Center
- Addressed 'real world' questions and options that applied to all users
- On-site training allowed for more valuable brainstorming sessions
- Were able to spend sufficient time on areas specific to users and environment
"We wanted focused training and being on site allowed better management of our time." – MD Anderson Cancer Center
- Helped sustain compliance with GMP 21 CFR Parts 210-211
- Connected departments company-wide to quality system
- Improved collaboration between employees and departments
"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." – Stay InFront
- 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
"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." – ARUP Laboratories
- 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
"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."
– Iowa Blood
- 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
"Being the first to market with an innovative product is crucial in our industry and MasterControl is the key to making this happen."
– Weider Nutrition
- Eased the document management workload (artwork, SOPs, case studies, regulated information, etc.)
- No need for a dedicated server or onsite IT person
- Enabled users to access documents from home, the office or on the road
"MasterControl's eQMS has helped improve ease-of-access to important information, making us more efficient and productive."
– Zarbee's Naturals
- 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
"Hard copy documents are no longer needed by manufacturing to assemble products. Now everyone can access assembly documents from online with MasterControl." – Asymtek
- Expanded its document control system to include the training module
- Configured MasterControl with other modules for an optimal document control system
- Implemented best practices for users' diverse languages and limited computer resources
"The fact that our Dominican users can now select Spanish language when they use the system was a giant hit, which is definitely a plus for MasterControl" – Ecolab