Company Overview: Accelerating Compliance Since 1993
MasterControl Inc. was founded in 1993 as a document control solution provider. Since that time, the company has grown significantly. Today, MasterControl provides a full line of industry-specific quality and compliance software solutions and services to hundreds of satisfied customers worldwide. Our offerings enable regulated companies to accelerate compliance and get to market faster while reducing costs and improving efficiency.
Solutions: MasterControl offers an array of products and pricing options for organizations of all sizes, from small start-ups to global companies with thousands of employees. Our integrated solution allows you to define, track and manage all of the individual quality processes that are critical to regulated companies in one seamless environment—instead of juggling multiple solutions from multiple vendors. This reduces your cost of compliance and increases your competitive advantage.
Services: In addition to software, we provide a myriad of services to help you implement your enterprise quality management system (QMS) quickly—without taxing your internal resources. To ensure that your solution continues to operate at the peak of efficiency or to accommodate growth or change, we also provide ongoing education, training and support services.
Regulations: We work closely with regulatory bodies like the FDA to stay on top of regulatory requirements. Our solutions are designed to comply with the most rigorous regulations (such as FDA, MHRA, EMA and MHLW rules), guidelines (including EU Annex 11 and ICH) and standards (ISO, GxP, EU GMP).
ISO 9001:2015 Certification: In November 2015, MasterControl reached a milestone as one of the first companies in the world to successfully complete a certification audit to the ISO 9001:2015 standard. The certification demonstrates that MasterControl products and services maintain the highest quality.
We're Proud of the Company We Keep.
MasterControl Customers: At MasterControl, customer success is the core value on which we base our entire business operating philosophy. We take great pride in our innovative solutions, but we take even greater pride in helping some of the most trusted, well-respected leaders in the life sciences and manufacturing industries put that innovation to work throughout their organizations. At present, more than 800 customers, with more than 1,000 customer sites and nearly 1,000,000 users worldwide rely on MasterControl to help them deliver their life-saving products to more people sooner.
Thought Leadership: It's Not Just a Buzzword at MasterControl.
At MasterControl, we realize that you need more than products and solutions, you need expertise, guidance and resources to continue to be great at what you do. We strive to provide you with all of these things through a variety of channels:
Executive Leadership Team: Senior management at MasterControl is 100 percent committed to the success of our customers, partners and employees. Each team member brings the expertise, judgment, leadership and diversity of thought and experience needed to make the best decisions for all of our stakeholders.
Industry Experts: At MasterControl, product development is driven by seasoned product managers with decades of industry expertise, not software engineers. Having been in your shoes, they understand your goals and respond with solutions and services that offer you real, tangible value—and are compliant with the latest industry standards. These experts also share their ideas and insights with you via our blog, social media channels and events.
MasterControl Speakers Bureau: The MasterControl Speakers Bureau addresses and educates quality and compliance professionals at association events, trade shows, forums, conferences and analyst meetings—free of charge. They offer a constant source of guidance in today’s volatile regulatory environment.
GxP Lifeline Blog and Social Media: Biweekly, we publish insightful posts from MasterControl experts and some of the industry’s leading external quality and compliance thought leaders. Our blog is just of many resources in our vast education library. We also offer industry-specific newsletters, white papers, videos, webinars and case studies—all free of charge. You can also interact with us on LinkedIn, Twitter, Google+ and Facebook
Events: We love an opportunity to gather face-to-face with our customers or prospects or both to share experiences, best practices and ideas. From our global annual user conference to intimate regional user groups and dinners, the MasterControl event roster is bursting with fantastic events in both North America and abroad.
Celebrating Success Through the Gift of Giving.
Community Focus: As more people turn to MasterControl to achieve their quality and compliance goals, we continue to grow —an incredible 30 percent annually since 2001. With this growth, it is increasingly important to us as a company to give back to the community in which we live and thrive.
Careers at MasterControl: Fun, Flexible and You Get to Make a Difference. If you are one to follow job search websites like Glassdoor, Monster, Indeed.com and others, we encourage you to look up MasterControl. You will find that most sites describe us as a fantastic place to work, which we are. However, we hire only “exceptional people;” it’s a core value. Do you have what it takes to work here?
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マスターコントロール株式会社では、文書管理ソフトウェア、品質管理ソフトウェアなどのソリューションを提供しています。 品質や文書管理ソフトウェアを使用して、ワークフローや適合性、SOPの電子化、CAPA（修正措置や予防措置）のデータ管理、ISO 9000やISO 14000、QS-9000、そしてFDA 21 CFR Part 11などの規制下の企業様にご利用いただけます。また、21 CFR Part 11やISOなどに準拠したテスト計画書の作成やコンサルティングサービスなどのバリデーションに関するサービスも提供しています。
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.