SALT LAKE CITY, UT, USA – November 20, 2008 – MasterControl Inc., a leading provider of GxP and business process management software solutions, announced today the availability of the MasterControl MD™ software solution. MasterControl MD™ helps medical device manufacturers to get their products to market faster without sacrificing regulatory compliance.
“MasterControl MD is a utopian end-to-end solution that allows cross-functional teams to efficiently collaborate on critical documents and processes and speed up the development cycle,” said Matthew M. Lowe, MasterControl Senior Product Manager, Medical Device Expert. “MasterControl can help every team in a medical device company to streamline their processes, whether they are working in product development, manufacturing, operations, quality, purchasing, or regulatory departments.”
MasterControl MD’s out-of-the-box, best practices configuration for compliance to standards such as 21 CFR Part 820 and ISO 13485 can help medical device manufacturers get their products to market faster by enabling the entire development team to execute and communicate their tasks more efficiently using tools with which they are already familiar and proficient. Benefits of implementing MasterControl MD include:
* Collaboration workspaces that involve multiple departments, outside suppliers, consultants, and other parties
* A means to effortlessly organize design history files and technical dossiers
* A Web-based platform that maximizes the effectiveness of design reviews and smoothes the design transfer to manufacturing with electronic collaboration and approval across geographically dispersed design teams
* Automated approval workflows that reduce time wasted waiting for approvals
* Capability to involve manufacturing, marketing, quality, and regulatory teams early in the development cycle, which ultimately improves the probability of product success
Departments and teams in medical device companies that can benefit from MasterControl MD include:
* Engineering and product development teams can use MasterControl to more easily manage the continual flood of product spec iterations and keep manufacturing, purchasing, document control, and the supply chain up to date. MasterControl MD allows design engineers continue to work with the CAD applications with which they are already familiar while simultaneously helping them remain in compliance without hampering the development cycle.
* Manufacturing and operations departments are connected to the development process early on, allowing them to provide input that can reduce manufacturing costs and line up the supply chain sooner. MasterControl ensures that documentation used in the manufacturing process is always up to date and includes robust training management tools that affirm that operator training records are always kept current.
* Quality managers can use MasterControl’s built-in analytics tools and scheduled reports to trend and track quality metrics. MasterControl simplifies compliance without compromising efficiency by automating quality events such as CAPA, eMDRs, complaints, NCMRs, and audits with electronic signatures and workflows. Employee training records are automatically maintained with robust links to MasterControl’s document management system. MasterControl also leverages the quality feedback loop in order to minimize failures in the field and improve product design. MasterControl helps quality professionals avoid common QMS pains—such as CAPA, complaints, and audits—and provides more insight into the development process and resulting documentation. The system also makes it easier to maintain a rapidly evolving approved vendor list (AVL) and helps insure that it is utilized properly.
* Purchasing departments have a single source for product specifications and approved vendor information. Managers have visibility into changes to processes, which enhances efficiency and prevents rework and product scrap. MasterControl MD ensures that purchasing decisions are always based on accurate, up-to-date data.
* MasterControl gives regulatory professionals a means to easily collaborate with the cross-functional development team to assemble documentation for submissions to regulatory bodies such as the FDA. Correspondence with regulatory agencies may be stored and tracked in MasterControl, thus providing a single access point for all regulatory information. MasterControl also simplifies and automates the processes and systems that must be in place for ISO 9000 certification.
MasterControl MD makes efficiency and compliance synonymous throughout the organization by providing tools that streamline product development and quality. Quality professionals can maintain compliance without hindering the development cycle while simultaneously improving overall product quality by incorporating failure and complaint data into future designs. All supplier-related quality information can be accessed from a single interface, which facilitates rapid assessment. MasterControl’s automated status tracking functionality ensures supplier compliance. Regulatory specialists can utilize MasterControl to participate in the development cycle and repurpose documentation for use in regulatory submissions with ease.
An integrated enterprise system, MasterControl MD serves as a single source for product definition. The system provides a central repository for all drawings, specs, manufacturing procedures, inspection criteria, marketing collaterals, bills of materials (BOMs), and other critical documents. MasterControl MD features tightly integrated applications and it seamlessly integrates with the tools users work with every day such as CAD, Outlook, Word, MS Project, and so forth.
MasterControl’s advanced document-based approach takes document control and process streamlining beyond just engineering—users in any department can effortlessly collaborate on the same document using familiar applications. MasterControl MD makes supply chain management more efficient and helps avoid receiving delays, product scrap, and rework. MasterControl gives managers an overview of the development pipeline and insures that purchasing decisions are always based on accurate, up-to-date data.
The products that comprise the MasterControl MD solution are:
* MasterControl Documents™
* MasterControl Process™
* MasterControl Training™
* MasterControl Supplier™
* MasterControl PDM Connectors™
* MasterControl Portal™
* MasterControl PDF Publishing™
* MasterControl Business Process Library™
* MasterControl Exams™
* MasterControl IQ/OQ™
* MasterControl TOQ™
* MasterControl DHF Jumpstart
* MasterControl DHF Jumpstart PQ™
* MasterControl PQ for Business Process Library™
The MasterControl Documents, BOM, Projects, Supplier and PDM Connector solutions inclusive in MasterControl MD provide medical device companies with core functionality for product lifecycle management (PLM) while simultaneously maintaining ease of use and accessibility for the entire enterprise.
For more information about how MasterControl MD can get your product to market faster by improving your medical device company’s development processes, contact a MasterControl representative.
About MasterControl Inc.
MasterControl Inc. is a global provider of GxP process, quality audit and document management software solutions for life science companies. MasterControl™ products are easy to use, easy to deploy, easy to validate, and easy to maintain. They incorporate industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Nearly 400 companies, more than any other QMS provider, currently use MasterControl solutions for easier compliance, faster validation, and better process management. For more information about MasterControl, visit www.mastercontrol.com, or call 800-825-9117 (U.S.) or +44 118 9812838 (Europe).