Safety computer systems

The development of computer capabiUties in hardware and software, related instmmentation and control, and telecommunication technology represent an opportunity for improvement in safety (see COMPUTER TECHNOLOGY). Plant operators can be provided with a variety of user-friendly diagnostic aids to assist in plant operations and incipient failure detection. Communications can be more rapid and dependable. The safety control systems can be made even more rehable and maintenance-free. Moreover, passive safety features to provide emergency cooling for both the reactor system and the containment building are being developed. 

HWeS Hazardous Waste Computer System National Safety Council P.O. Box 11933 Chicago, IL 60611 (800) 621-7619 (312) 527-4800... 

Nimmo, S. R. Nunns, and B. W. Eddershaw, Lessons Learned from the Failure of a Computer System Controlling a Nylon Polymer Plant, Paper presented at Safety and Reliability Society Symposium, Altrincham, UK, Nov. 1987. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

When these latent conditions create an unfolding situation, the safety barriers present in an organization can be seriously affected. Svenson (Svenson, 2001) identifies three functional categories of safety barriers, e.g. technical, human, organizational. These safety barriers can be activated by different safety barrier systems, such as the closure of a valve automatically by a computer or manually by an operator. Moreover, a safety barrier system can (simultaneously) operate more than one safety barrier, like an operator who can close a valve, connect a hose, or a computer which closes down a machine and alerts an operator, etc. 

ADEs and medication errors can be extracted from practice data, incidents reports from health professionals, and patient surveys. Practice data include charts, laboratory, prescription data, and administrative databases, and can be reviewed manually or screened by computer systems to identify signals. A method of ADE and medication error detection and classification has been presented that is feasible and has good reliability (Marimoto et al. 2004). It can be used in various clinical settings to measure and improve medication safety. 

The distributed control system (DCS) hardware areas are often referred to as "process computer rooms." I/O Rooms contain the incoming and outgoing wiring, cables and data highway links, and often small transformers and other related electrical equipment. Often, additional space is needed for a master process engineering computer terminal/work station for process control system changes and for critical safety instrumented systems (SIS) for interlocks and emergency shutdowns. 

Computer systems are used worldwide in the pharmaceutical industry and have direct bearing on product quality. The purpose of validation is to demonstrate that the intended product manufactured, packed, or distributed using a computerized controlled system will meet the safety, efficacy, and potency requirements per the individual monograph. 

All data generated in a computer system must be available, secure, and safely stored. Unauthorized people cannot have access to data files. It must be impossible to overwrite any data, but all recalculation required must generate a new data and not substitute the previous one. Safety procedures must be available. Data should be backed up periodically following specific SOPs, and backup copies must be iden-... 

The decommissioning procedure must address both operational and safety aspects of the computer system application and establish integrity and accuracy of system data until use of the system and/or process is terminated. For quality-related critical instrumentation, proof of calibration prior to disconnection is needed. 

Computer systems validation, implied in 21 CFR Part 211.68, established in 21 CFR Part 11.10(a), and defined in the recent draft FDA guideline,4 is one of the most important requirements applicable to computer systems performing regulated operations. Computer systems validation is the confirmation (by examination and the provision of objective evidence) that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled. It involves establishing that the computer system conforms to the user, regulatory, safety, and intended functional requirements. 

Each phase of the SLC must be controlled to maximize the probability that a finished system meets all quality, regulatory, safety, and specification requirements. If an SLC approach is applied properly, no additional work will be required to validate a system. For each SLC period and event, computer systems validation requires that the development processes are documented work products. As explained in Chapter 2, phase gate verification activities performed during each event may be a perfect place to review and quantify the quality of all products needed to support the next phase. 

Computer systems used to control, monitor, or record functions that may be critical to the safety of a product should be checked for accuracy at intervals of sufficient frequency to provide assurance that the system is under control. If part of a computerized system that controls a function critical to the safety of the product is found not to be accurate, then the safety of the product back to the last known date that the equipment was accurate must be determined. 

Operational checks are normally presenting process control computer systems. These systems may contain code that is part of the master production record. At the system level, the purpose of operational checks is to execute algorithms, sequencing of operations, and safety-related functions as required in the applicable customer specification. Inspections and testing are fundamental processes to be performed during the validation of critical system sequences. In addition, an ongoing program must be established to frequently verify that critical operations occur in the proper sequence. 

After the computer system is put into operation and all appropriate validation documentation has been collected, as defined in the validation plan, the entire validation documentation package should be archived to ensure its safety and security. 

During product research, production, and control of FDA regulated products, documentary evidence must be retained for a certain period, which prove the safety and efficacy of the product. When a computer system is to be retired from active use, the data from that system must be archived. Some regulations which cover FDA regulated products, and which require records to be retained, are listed in Table E-l. 

These revised regulations require the validation of computer systems. Systems covered by device GMP regulations include any system that directly or indirectly impacts the safety, effectiveness, or quality of materials, components, or the finished device. 

Cichocki, T. and J. Gorski, Failure Mode and Effect Analysis for Safety-Critical Systems with Software Components, in Floor Koomneef, Meine van der Meulen (eds.) Computer Safety, Reliability and Security, Proceedings of 19th International Conference SAFECOMP 2000, Rotterdam (The Netherlands), October 24—27, 2000, Springer Lecture Notes in Computer Science 1943, p. 382-394. 

Cichocki, T. and J. Gorski, OF-FMEA—an approach to safety analysis of object oriented software intensive system, The International Conference on Advanced Computer Systems (ACS 2002), Miedzyzdroje (Poland), October 23-25, 2002 (published in The Kuwer International Series in Engineering and Computer Science - 752, ISBN 1-4020-7396-8, September 2003, p. 271-280). 

McDermid, J. A., A.J. Vickers, and S.P. Wilson, Managing Analytical Complexity of Safety Critical Systems using Viewpoints, Department of Computer Science, University of York, UK. 

With increasingly networked, distributed computer systems the risk of deliberate malicious interactions, using software-based tools, became a serious threat. Many-fold related issues like data protection, privacy, integrity, authenticity, and denial of service attacks, viruses, worms etc. lead to a separate community to be established, which is nowadays in the main focus of the public as was safety some time ago (and still is—but only after catastrophic events). This community developed separate standards, methods, taxonomy and ways of thinking. 

Unfortunately, the gap has not been spanned by these approaches. As far as I know, only JRC Ispra has once financed a project of EWICS TC7 (European Workshop on Industrial Computer Systems, TC7, Safety, Reliability and Security, an expert group in this area), on Study of the Applicability of ISO/IEC 17799 and the German Baseline Protection Manual to the needs of safety critical systems (March 2003)(www.ewics.org) (3), where the gaps between the security standards and the safety-related system evaluation requirements have been analyzed for several sectors (medical, railways, nuclear, electric power networks) and in general. 

Modem computer systems are often used for processing, storing and transferring restricted information. These information systems have certain safety requirements and should maintain confidentiality. The easiest way of solving this problem in open systems is using cryptography. 

HWeS Hazardous Waste Computer System National Safety Council P.O. Box 11933 Chicago, IL 60611 (800) 621-7619 (312) 527 1800 Tracks waste from collection to treatment. Database of 2,600 common chemicals which provides the EPA number for each chemical, DOT ciassincation for hazardous waste transport, and permit information. Templates for all required forms, labels, and notices. 

One year later the U.K. Department of Health (DoH) GLP Monitoring Unit pubhshed its expectation for computer systems in laboratories conducting human health and environmental safety studies.23 It identihes laboratory management responsibilities for ... 

The FDA has recently highlighted the importance of risk management as part of 21st century compliance. Other regulatory authorities such as MHRA share this perspective. Without risk management, computer validation costs can quickly become prohibitive. Taking the highest level of compliance for all aspects of a computer system will not necessarily lead to discernible, increased patient/consumer safety. 

DIA (1988), Computerized Data Systems for Nonclinical Safety Assessment Current Concepts and Quality Assurance, Red Apple Report, Drug Information Association, Maple Green, September. BARQA (1997), Regulatory Compliance and Computer Systems, Conference Proceedings, January 7-8, Cambridge, U.K. 

These computer systems should be prospectively validated because only by so doing can one be assured that they will reliably and consistently meet their intended function, all relevant regulatory requirements, and most important of all, the safety of the blood recipient. 

IS015189 Medical Laboratories—-Particular Requirements for Quality and Competence is a universal standard for quahty management in medical laboratories that specifies requirements in general terms applicable to all medical laboratory fields, The standard is intended to form the basis for accreditation of medical laboratories. In addition to general laboratory conditions in relation to quality control, the standard focuses on medical competence, interpretation of test results, selection of tests, reference intervals, ethical aspects, and safety. An annex concerns quality management of laboratory computer systems. 

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