As the leader in providing integrated quality management software systems to companies all around the world, MasterControl is making news and leading the way in solving business problems for all types of regulated manufacturers.
SALT LAKE CITY – December 14, 2007 – MasterControl Inc., the global leader in GxP process management solutions for the life sciences industry, today announced the development of a connector between MasterControl and the PDMWorks® product data management solution from SolidWorks Corporation. The interface with PDMWorks allows collaboration and redlining on PDF drawings while insuring that the PDF copies in the MasterControl document control management system stay in sync with the native files in the PDMWorks solution.
“The MasterControl PDMWorks connector facilitates the secure handling of complex CAD files and helps companies in regulated environments overcome common product data management challenges,” said Matthew M. Lowe, MasterControl product manager, medical device expert. “The automated routing and approval made possible by MasterControl’s interface improves workflow functionality and allows effective, seamless management of CAD files.”
MasterControl’s easy-to-use system manages and tracks the creation, modification and archiving of all information relating to a product. The interface provides users with straightforward means of applying document control to CAD data without forcing designers to use a non-native application for managing CAD files. CAD files are maintained by the native PDMWorks software system while MasterControl creates PDF copies for official document control purposes such as routing, approval and production.
Users across an organization—even those who lack detailed knowledge of the CAD package—can redline and collaborate on drawings using nothing more than Adobe Reader®. When collaboration introduces new changes, collaboration leaders can make the necessary modifications using the native CAD application. The MasterControl system then automatically publishes a new PDF file reflecting the changes made.
MasterControl provides continuous and automatic monitoring for new and revised released-state drawings in the PDMWorks solution. The system publishes a PDF main file for each new drawing using the metadata from the PDMWorks software system. Similarly, revised drawings trigger revisions in MasterControl which pushes the metadata from the PDMWorks solution to updated MasterControl “InfoCards.” InfoCards are created for each new and revised drawing at a user-defined state in the PDMWorks solution, automating the publishing process and allowing drawings to be routed for collaboration and approval. The InfoCards link to native drawing files, which simplifies referencing when the time comes to revise drawings. The InfoCards also support custom field data that can be directly passed from the SolidWorks PDMWorks software system.
When the link between MasterControl and the PDMWorks software system is initialized, the system automatically synchronizes packets of files until there are no more files requiring synchronization. The MasterControl system can also be manually synchronized and still identify and rectify any gaps that may exist. If missing metadata in the PDM system causes the transfer process to fail, the MasterControl system automatically notifies assignable users.
MasterControl’s PDMWorks connector fosters an effective communication environment and helps maintain regulatory compliance by insuring that data is kept consistent between systems. MasterControl also features electronic signature capabilities, time-stamped audit trails, dual passwords for document approval, and password certification, expiration, and encryption. MasterControl’s PDMWorks solution works seamlessly with MasterControl BOM™ to provide a cohesive organizational structure throughout the design and manufacturing processes.
About MasterControl Inc.
MasterControl is a leading provider of document management and GxP process solutions for life sciences companies around the world. MasterControl automates and effectively manages document control, change control, audits, corrective/preventive actions (CAPA), regulatory training, nonconformance disposition, customer complaints, and other GxP processes. The MasterControl solution is easy to use, deploy, validate, and maintain. MasterControl employs industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance with requirements such as ISO standards, FDA regulations, and the Sarbanes-Oxley Act. 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. For more information, visit the MasterControl website, or call 800-825-9117 toll free.
About SolidWorks Corporation
Concord, Mass.-based SolidWorks Corporation has provided cutting-edge, straightforward 3D CAD tools to designers and engineers in technology, medical, scientific, industrial, transportation, educational, and consumer markets since 1993. SolidWorks CAD, PDM and Product Lifecycle Management (PLM) applications are vital tools for the development of new medical devices and other life science technologies. More than 500,000 engineers and designers worldwide utilize SolidWorks’ intuitive, high performance products. For more information about SolidWorks Corporation’s products and services, visit the SolidWorks corporate website.