Sarbanes-Oxley
To ensure accurate reporting of financial data, the Sarbanes-Oxley Act (SOX) requires corporate IT governance programs with effective internal controls over the financial reporting process. Several popular IT frameworks, including COBIT, COSO, CMMI, and ITIL, can be leveraged to achieve this. Regardless of the framework, however, companies want more out of their SOX initiative than just compliance. These initiatives must also support the overall business strategy, meet the requirements of all stakeholders, and be flexible enough to accommodate the changing demands of the enterprise and external regulations. Achieving sustainable compliance with Sarbanes-Oxley demands solutions that can automate and enforce compliant and efficient business and IT processes. Telelogic® System Architect® for financial and business process modeling, Telelogic® DOORS® for Requirements Management, Telelogic® Synergy™ for Change and Configuration Management, and Telelogic® Dashboard™ help organizations institute a program for sustainable compliance and achieve IT governance while delivering added value.
FDA Compliance
As life-saving technologies rapidly change the face of healthcare, medical device manufacturers are challenged to develop evermore complex solutions more efficiently. These projects go far beyond typical development tasks. Manufacturers must prove that their devices meet the stringent safety requirements in compliance with the FDA Quality System Regulation (QSR). Failure to provide complete requirements traceability can not only delay FDA QSR compliance but also the overall validation process, resulting in late time-to-market and missed business opportunities. In addition, medical device manufacturers must be ready to instantly produce an audit trail relative to any application, process, or manufacturing change. Therefore, it is critical that the following best practices support the quality and safety of medical devices throughout the development lifecycle. Achieving sustainable compliance with FDA Regulations demands solutions that can automate and enforce compliant and efficient development processes. Telelogic DOORS for requirements management, Telelogic® Tau® for design and development, Telelogic Synergy for change and configuration management, and Telelogic Dashboard help organizations institute a program for sustainable FDA compliance.
Learn More about the Frameworks and best practices affecting your business by selecting the relevant module below:
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