Supporting corrective and preventive action (CAPA) practices, a quality system software application for medical device manufacturing has user-friendly and democratic collaboration features designed to maximize an organization’s level of participation in CAPA and ensure that CAPA teams generate high-quality documentation. The Windows-based AcQualis program automatically updates on every PC in an organization, and a fast, secure Microsoft SQL Server 2005 database can provide nearly instantaneous response. Licensed by concurrent users rather than installed seats, it is available to everyone at a company anytime. A rules engine allows administrators to specify the stages that a document goes through and the rules that govern its readiness for the next stage. Additional features include connectivity to an enterprise resource planning system, built-in search and reporting functions, and regular background saves to the local hard drive.
A company offers a flexible enterprise resource planning (ERP) software system designed to meet the regulatory and tight process control challenges of medical device manufacturing. Featuring capabilities in product data management, quality process control, and cradle-to-grave product traceability, the medical device ERP software provides a framework for managing product innovation. By including functionality that supports device manufacturers’ extended operations—such as financial management, customer-relationship management, quality management, product life cycle management, supply-chain management, global business management, and advanced planning and scheduling—it exceeds the scope of traditional ERP, according to its manufacturer.
Medical device engineers and researchers can use an upgraded medical technology Fortran compiler for testing prototypes. Featuring more information in run-time messages, more Fortran 2003 features, and a multithreaded I/O library, the Fortran Builder 5.2 checking compiler offers virtually complete implementation of the latest Fortran 2003 standard and an integrated development environment, according to the company. Designed for the Windows platform and providing a Fortran-aware editor, build system, GUI debugger, and help system, the portable compiler delivers standards conformance. It interprets Fortran standards precisely and incorporates such run-time checking features as procedure interface checking across multiple files, undefined variable trapping, and memory-leak detection.
Numerical Algorithms Group Inc.
Product life cycle management system
A product life cycle management (PLM) software system for small and medium-sized medical device and equipment manufacturers is designed for rapid implementation. The RapidStart PLM suite offers features for improving product development, such as product data management, bill of materials management, engineering change and engineering change order management, document management, compliance management, and integration with engineering environments. It can also be scaled to incorporate additional functionality, such as corrective and preventive action and training-record management capabilities, from other PLM systems. The software suite helps device manufacturers to meet 21 CFR Part 11 guidelines by providing a central location for managing product data and tracking electronic audit trails, logging password-protected electronic sign-offs, and maintaining lists of authorized signatures.
Document control system
Providing compliance management, process mapping, and analysis software, a vendor offers a process-based, on-demand document control system that works as a software-as-a-service subscription application. Document Control On Demand software is intended to help medical product manufacturers to graphically map business processes through its Allclear application and to integrate a Web-based document control tool. Providing security and supporting compliance with applicable ISO and FDA regulations, the digital service features a fast implementation cycle, quick start-up, flexible licensing, and no hardware costs. Organizations can use this on-demand software to save time and economize in the management of regulatory compliance, achieving real-time life cycle control of their documents and processes, according to its manufacturer.