Software certification

All basic codes used in safety analysis are certified by the Council on Software Certification of the Russian regulatory authority. 

Espinoza, H., Ruiz, A., Sabetzadeh, M., Panaroni, P. Challenges for an open and evolutionary approach to safety assurance and certification of safety-critical systems. In First International Workshop on Software Certification (WoSoCER), pp. 1-6 (2011)... 

Maibaum, T.S.E., Wassyng, A. A product-focused approach to software certification. IEEE Computer 41(2), 91-93 (2008)... 

Sljivo, I., Gallina, B., Carlson, J., Hansson, H. Strong and weak contract formalism for third-party component reuse. In IEEE 3rd International Workshop on Software Certification (WoSoCer) (November 2013)... 

The amount of code coverage testing that should be performed depends on the safety certification level desired for the software. The most stringent coverage, MC/DC testing (or equivalent), is required by the Radio Technical Commission for Aeronautics (RTCA)/DO-178B for Level A software certification. 

Nevalainen, R., Slotosch, O., Truscan, D., Kremer, U., Wong, V. Impact of multicore platforms in hardware and software certification. In Workshop on Industry-Driven Approaches for Cost-effective Certification of Safety-Critical, Mixed-Criticality Systems (WICERT) (2013)... 

Miller 1989] D. Miller. The role of statistical modelling and inference in software quality assurance, in Software Certification, Barking, Elsevier Applied Science, 1989. 

The combination of hardware and software certification means that the end user can obtain a fully certified product for the logic solver section of the SIS. This does not of course relieve the end user of any obligations as far as the quality of his software application/configuration... 

The LIMS software is essentially a database for tracking, reporting, and archiving lab data as well as scheduling and guiding lab activities. Graphical and statistical treatment of data for improved process control (qv) as well as preparation of certificates of analysis (COA) for the customer are some of the other features of a comprehensive LIMS package (30). 

You will need to review the requirements and the resultant design to identify any special equipment, tools, test software, and test or measuring equipment required. Once identified, plan for its design, manufacture, procurement, verification, and certification. One way of doing this is to produce a list that contains the following details ... 

Good Laboratory Practice (GLP) The system provides a comprehensive feature set to aid customers in meeting GLP requirements. This includes features such as certificate-of-software validation, user-access levels, instrument and sequence logbooks, system-suitability software for aU supported HP instruments, standard GLP reports, and a GLP save option that encrypts and saves data and methods together. 

Increased team expertise by mentoring new adjusters, training them on new estimating software and wireless technology, and conducting quarterly skills certification exams which were correlated with pay raises and bonuses... 

Project Quality Plan Software Quality Assurance Program Functional Design Specification Hardware Design Specification Software Design Specification Software Module Design Specification Software Review Software Module Test Records Hardware Test Records Integration Test Records Instrument Spccs/Data Sheets Instrument Calibration Records Material Certificates... 

The TickIT Guide—Using ISO 9001 2000 for Software Quality Management System Construction Certification and Continual Improvement. British Standards Institution (January 2001, issue 5.0). 

The following documents supplied by the manufacturer can be used as part of this qualification description and instruction manual, installation drawings and instructions, test and take-over certificates and software documentation. It is recommended to list and specify all necessary documents and their format in the purchase order, as this reduces time and effort for both the buyer and the seller. 

One well-known product based on PKCS is the PKI. PKI is a combination of software, encryption technologies, server platforms, workstations, policies, and services used for administering certificates and public-private key pairs. 

Cost-effectiveness and mass deployment of critical systems in combination with non-critical systems is a trend, where many other application areas will benefit from, so that there is a clear need not only for application-specific ICT-technology, but for generic dependable ICT-technology (hardware, software, SoC (Systems-on-Chip), building blocks, communication) which fulfils the requirements of generic functional safety and security standards as well as of sector-specific ones (certification to create trust in these systems ). 

An assessment for certification can be performed on the basis of simulations only, due to the complexity of the relations pointed out above. The software developed for it enables qualified statements concerning the power distribution on cables including bus connections. Here, concerns of explosion protection are taken into account. The aim of these investigations is a statement valid in general for the intrinsic safety at different bus configurations. 

The definition of supplier validation activities and documentation should be embedded in contractual agreements. In addition, suppfiers should agree to potential inspection by GxP regulatory agencies and Supplier Audit by pharmaceutical and healthcare companies. Supplier Audits can be conducted by the pharmaceutical or healthcare company s own personnel or, if this would compromise the supplier s commercial interests, by an independent software quality assurance auditor, consultant, or validation expert employed by the pharmaceutical or healthcare company. Auditors must be suitably qualified, for example by independent certification by examination to the quafity system standards such as ISO 9001 2000. Suppfier Audits are discussed in detail in Chapter 7. 

The integration of the computer system (hardware, software, and instrumentation) must be confirmed in readiness for the subsequent OQ activity. Some practitioners have referred to this as the testing of static attributes of the computer system. The importance of completing the IQ before commencing the OQ can be illustrated by a recent incident in which a pharmaceutical company had over 35% of the instrumentation for a multiproduct plant but did not have available calibration certificates. There were various reasons for this, but none were recorded. Some instruments were no longer used, some had extended recalibration periods, and some had been undergoing calibration for several weeks. The net effect was that the computer system under quahfication was clearly not in a controlled state suitable for the OQ, and in consequence, it was not ready for use. 

Defines the quality of the software from supplier s perspective (certificates)... 

Major suppliers of CDS will usually provide certificates of training for installation of the system and software. However, a major weak spot with many CDS that have the IT Department running the system is that they do not have training records or cnrricnla vitae. 

Snppher staff They were responsible for the installation and initial testing of the data system software, and left copies of their training certificates listing the products they were trained to work on. These were checked to confirm that they were current and covered the relevant products and then included in the validation package. 

PLC-based systems are similar to solid-state systems. They nse the same field interface cards and have the same level of certification but the logic functions are performed by software. They are also easier to interface to other systems (via serial commnnications) in order to notify the system of a failnre. The PLC used is subject to rigorous source code (machine level) inspection and testing by an independent certification body (e.g., TUV in Europe) to examine the safety integrity of the code, inclnding all possible failure paths. The PLC system (application software and hardware) should be developed and tested using a formal, hfe-cycle methodology. ... 

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