Systems integration mandates

Systems integration must be performed on the Systems Architecture Configuration Items so that external interfaces and hardware, software, and operational implementations at the next level of detail for all elements will seamlessly fit into their intended functions. System interfaces are captured in schematics, interface diagrams, tables, and drawings of interface data. Some industries mandate that an Interface Control Document (ICD) be delivered to ensure hardware form, fit, and function. 

Facility System Safety (FSS), which is the application of system safety concepts to the facility acquisition process, has recently gained acceptance throughout the Department of Defense and most recently within the Department of Army with the conception of SAFEARMY 1990. The Army s goal is to fully integrate the total system safety, human factors, and health hazard assessments into continuous comprehensive evaluation of selected systems and facilities. The Chemical Research Development and Engineering Center (CRDEC) has mandated appropriate levels of system safety throughout the lifecycle of facility development for many reasons. These include ... 

In the U.S., proficiency testing has been held to be of utmost importance in accreditation programs and is typically mandated wherever it is possible to conduct. European systems of accreditation have been slower to include proficiency testing as an integral part of accreditation, but, in recent years, have begun to make greater use of proficiency testing. 

MANDATE (Manufacturing Management Data Exchange), 1782 Mandatory collaboration, 605 Man-Machine Integrated Design and Analysis System (MIDAS), 2413, 2429-2440 aviation case studies, 2436-2440... 

Various stakeholders have recognized the need to improve current pharmacovigilance practice and the opportunities that exist to expand the use of observational data in that pursuit (Berlin 2008). In 2007, the U.S. Congress passed the FDA Amendment Act, which in part mandated the "establishment of a postmarket risk identification and analysis system" that leverages observational health-care data, including administrative claims and electronic health records (EHRs), to monitor approved medicines on a periodic basis. In response, FDA established the Sentinel Initiative, an effort to create and implement a national, integrated, electronic system for monitoring medical product safety (Platt et al. 2009). 

Both lEC 61508 and DEF STAN 00-55 mandate software development processes, with the implication that following the prescribed development process is essential to developing software of the required integrity. The use of Commercial off-the-shelf (COTS) software is increasingly prevalent in safety-related systems. However, the approaches prescribed by lEC 61508 and DEF STAN 00-55 cannot be used for COTS software, for which the system developer has little or no control over the development processes adopted. Furthermore, source code may not be available for COTS software, and hence many of the verification techniques recommended cannot be used. 

The major software safety standards promulgate a process-based approach. This approach is popular with developers as it offers clear guidance. However, it is difficult to argue that the mandated processes guarantee that the software product does not introduce intolerable risks. Moreover, process-based standards are not well suited to COTS software. Some new standards prescribe an evidential approach. These are better integrated with the system risks, but (currently) offer little guidance to developers and safety auditors. 

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