Medical Device Qualified Supplier Directory
MasterControl, Inc. Company Profile
Qualifications: ISO 9001, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
More Than 1,000 Regulated Companies and 5 of the World’s Top Regulatory Agencies Use MasterControl to Mitigate Risk, Ensure Quality and Accelerate Compliance
MasterControl is a committed team of quality,
regulatory and software experts who work to empower regulated companies to get
their products to market faster. Our quality management software solutions
reduce overall costs, increase efficiency and accelerate compliance. We offer a
suite of seamlessly integrated and scalable software solutions for quality
management, document control, product lifecycle management, supplier
management, audit management, risk management, training management and much
What Sets our Software Apart
- Connected EQMS (Single Platform): Our integrated, best-in-class solution allows customers to automate, track and manage enterprise quality management processes in one seamless environment. No more toggling between multiple applications from multiple vendors, wasting time and money.
- Mobile Access: Users can access critical compliance-centric documents and information and perform tasks using a tablet or smartphone, which boosts overall efficiency and productivity.
- Scalable Architecture: Our software provides functionality that is configurable for small organizations and scalable to meet the needs of the largest companies. The design allows customers to easily scale up (or down) according to their needs and integrates with other third-party solutions so that data is streamlined throughout different business areas.
- Hassle-free Compliance: Customers say our software is easy to use, easy to maintain and easy to validate, which gives them more time to focus on their core business objectives.
- More Choice and Flexibility: Our EQMS suite offers customers a complete choice of quality management applications and deployment options.
- Customizable: Customers can tailor our software to suit their business using extensions, plugins, templates and add-ons.
What Sets our Company Apart
- Financial Stability: In business since 1993, MasterControl is the most financially stable of all EDMS/EQMS providers. We have sustained almost 20% annual growth since 2008.
- Unparalleled Industry and Domain Expertise: At MasterControl, product development is driven by seasoned product managers with decades of experience working in the life sciences and other regulated industries. This real-world expertise allows us to build solutions that offer tangible value and meet key regulatory requirements.
- A History of Innovative Firsts: We are the first software provider to deliver a cloud-based EQMS for life science and regulated manufacturers; the first software provider to develop a transfer operational qualification (TOQ) methodology for accelerating software and system validation for life science companies; and the very first company in the world to successfully complete a full certification audit to the ISO 9001:2016 standard.
- End-to-End Support Services: In addition to our robust solutions, we provide consulting, training, validation and implementation services to help customers maximize their software.
- Minimal IT Support Required: Once configured, the system requires very little internal IT support to administer.
- Security is Paramount: Our world-class hosting center is certified to SSAE 16 and ISAE 3402 SOC 1 Type II and SOC 3 reports and is PCI DSS section 9 and section 12 compliant. We take the privacy and data security of our 1 million+ ...