The other GMP: good manufacturing practice and its importance in the validation of constructed pharmaceutical facilities

The work reported is part of an ongoing PhD study prompted by the particular difficulties encountered when two very different quality cultures interact (in this case Pharmaceutical industry clients and Construction industry providers). Pharmaceutical facilities have particular needs for their production requirements. Stringent regulations are set by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) (in the UK) and the Food and Drugs Administration (FDA) in the US. This creates special problems of quality when it comes to the commissioning, validation and hand-over of the building, as it appears to be at odds with the rather less demanding quality systems that are normally accepted in the construction sector. The aim of the research is to model an acceptable process for incorporating these stringent validation requirements into the design, procurement and construction processes. There is little or no specific academic literature on the subject, though the trades and professional press (particularly in the USA) provide some normative comment on the problem area. The main academic grounding of the research is in Systems Theory and empirical data is being collecting using a multiple case study approach. Research data was collected from a number of pharmaceutical facility construction case studies and was used to test and inform a best practice model of facility validation. The qualitative methods of participant and direct observation were used as the main information gathering tools. The paper reports on the regulatory expectations that influence the construction of projects of this type and the impact on the best practice model of validation

Encouraging versatile thinking in algebra using the computer

In this article we formulate and analyse some of the obstacles to understanding the notion of a variable, and the use and meaning of algebraic notation, and report empirical evidence to support the hypothesis that an approach using the computer will be more successful in overcoming these obstacles. The computer approach is formulated within a wider framework ofversatile thinking in which global, holistic processing complements local, sequential processing. This is done through a combination of programming in BASIC, physical activities which simulate computer storage and manipulation of variables, and specific software which evaluates expressions in standard mathematical notation. The software is designed to enable the user to explore examples and non-examples of a concept, in this case equivalent and non-equivalent expressions. We call such a piece of software ageneric organizer because if offers examples and non-examples which may be seen not just in specific terms, but as typical, or generic, examples of the algebraic processes, assisting the pupil in the difficult task of abstracting the more general concept which they represent. Empirical evidence from several related studies shows that such an approach significantly improves the understanding of higher order concepts in algebra, and that any initial loss in manipulative facility through lack of practice is more than made up at a later stage

Modern software cybernetics: new trends

Software cybernetics research is to apply a variety of techniques from cybernetics research to software engineering research. For more than fifteen years since 2001, there has been a dramatic increase in work relating to software cybernetics. From cybernetics viewpoint, the work is mainly on the first-order level, namely, the software under observation and control. Beyond the first-order cybernetics, the software, developers/users, and running environments influence each other and thus create feedback to form more complicated systems. We classify software cybernetics as Software Cybernetics I based on the first-order cybernetics, and as Software Cybernetics II based on the higher order cybernetics. This paper provides a review of the literature on software cybernetics, particularly focusing on the transition from Software Cybernetics I to Software Cybernetics II. The results of the survey indicate that some new research areas such as Internet of Things, big data, cloud computing, cyber-physical systems, and even creative computing are related to Software Cybernetics II. The paper identifies the relationships between the techniques of Software Cybernetics II applied and the new research areas to which they have been applied, formulates research problems and challenges of software cybernetics with the application of principles of Phase II of software cybernetics; identifies and highlights new research trends of software cybernetic for further research

Getting Things Done: The Science behind Stress-Free Productivity

Allen (2001) proposed the “Getting Things Done” (GTD) method for personal productivity enhancement, and reduction of the stress caused by information overload. This paper argues that recent insights in psychology and cognitive science support and extend GTD’s recommendations. We first summarize GTD with the help of a flowchart. We then review the theories of situated, embodied and distributed cognition that purport to explain how the brain processes information and plans actions in the real world. The conclusion is that the brain heavily relies on the environment, to function as an external memory, a trigger for actions, and a source of affordances, disturbances and feedback. We then show how these principles are practically implemented in GTD, with its focus on organizing tasks into “actionable” external memories, and on opportunistic, situation-dependent execution. Finally, we propose an extension of GTD to support collaborative work, inspired by the concept of stigmergy

Modern software cybernetics: New trends

The file attached to this record is the author's final peer reviewed version. The Publisher's final version can be found by following the DOI link.Software cybernetics research is to apply a variety of techniques from cybernetics research to software engineering research. For more than fifteen years since 2001, there has been a dramatic increase in work relating to software cybernetics. From cybernetics viewpoint, the work is mainly on the first-order level, namely, the software under observation and control. Beyond the first-order cybernetics, the software, developers/users, and running environments influence each other and thus create feedback to form more complicated systems. We classify software cybernetics as Software Cybernetics I based on the first-order cybernetics, and as Software Cybernetics II based on the higher order cybernetics. This paper provides a review of the literature on software cybernetics, particularly focusing on the transition from Software Cybernetics I to Software Cybernetics II. The results of the survey indicate that some new research areas such as Internet of Things, big data, cloud computing, cyber-physical systems, and even creative computing are related to Software Cybernetics II. The paper identifies the relationships between the techniques of Software Cybernetics II applied and the new research areas to which they have been applied, formulates research problems and challenges of software cybernetics with the application of principles of Phase II of software cybernetics; identifies and highlights new research trends of software cybernetic for further research

The Cybernetics Thought Collective: A History of Science and Technology Portal Project White Paper

This White Paper discusses the Cybernetics Thought Collective (CTC) team’s specific work to digitize a select portion of archival materials; investigate and experiment with natural language processing, named entity extraction, and machine learning software; begin investigating access interfaces for the portal; and ingest the digitized materials and machine-extracted metadata into the University of Illinois Library’s preservation repository and digital library. The pilot grant project enabled us to explore emerging methods for creating access to archival materials, which resulted in promising outcomes. In May 2018, the CTC team launched the prototype portal: ​https://archives.library.illinois.edu/thought-collective/​.National Endowment for the Humanities PW-253912-17Ope

Cybernetics of Conflict within Multi-Partner Technology and Software Engineering Programmes

Large technology and software engineering programmes, such as enterprise system pro- grammes, are increasingly implemented through a mixture of customer and specialist third-party resources. These multi-partner working environments can be thought of as a complex social system, which oftentimes experience various forms of conflict. This can be due to competing objectives and priorities of the various organizations, along with incompatibilities of team members within the work-based social network of the implementation programme. If not brought under control, conflict can lead to complex emergent behaviours and dynamics within the wider social network, which can severely impact the likelihood of successful programme implementation of these software-intensive systems. Using social network analysis and thematic coding analysis within a case study, we show that the project management of complex software-intensive implementations requires considerable focus on control and communication across the programme-wide social network of team members, which we represent as a cybernetic system. A conceptual framework has been developed that extends extant literature around conflict in teams by framing the individual projects and the overall programme-wide implementation as cybernetic systems. The conceptual framework illustrates how a cybernetics approach to conflict within enterprise system implementations, can provide new insights into how conflict develops within project teams. Finally, we argue that the cybernetic approach allows us to develop project management interventions to mitigate the risk of conflict development, or control and regulate conflict once it has developed. We conclude by setting the agenda for future research on how conflict can be controlled within the implementation of software-intensive systems, such as enterprise systems

A systemic evaluation of the implementation implications of an integrated, standard information system : the SAP implementation project as a viable system

Bibliography: leaves 107-108.Real-time, on-line, integrated software systems are a part of the latest technologies for large concerns as enablers for viability in an ever increasing competitive business environment. The SAP (R/3 and R/2) standard software is widely considered as one of the leading solutions and implementation projects have taken the world by storm. The software, which runs on client server systems since 1992, is expensive and takes time to install. Complete systems can run into the tens of millions of dollars and take from one to over three years to implement. The application of the software spans most of the processes of a business, logistics, finance, workflow and human resources as a real time, on-line and integrated information system enabler. Much of the data capture and some of the control aspects of the business are automated. With this sophistication comes a new level of complexity. An initial argument of the thesis is that the success of an investigation into the problems associated with SAP implementations will be dependent on the thorough development of the inquiry system as a framework for appreciating the implications of such projects. Question Which management research approach will provide useful knowledge of the situation, with challenges including variety of human interpretations and interests, the complexity of organisational regulation and the technical options of the software? A framework was developed by considering three levels for paradigms; philosophy, methodology and the application of the methodology. As a choice for the philosophical level, phenomenology was chosen with its regard for the importance of the mental models of an observer. Pragmatism, with its basis for attributing meaning on the consequences of holding a belief or assumption, is enabled by a bias towards systems thinking as an adequate way of determining an appropriate level of knowledge of possible consequences of a decision. The scientific method is the underlying guide for the inquiry process with its abductive, deductive and inductive stages. The base strength of the method, as presented by Peirce (Smith, 1995), was experienced as the rigorous attention to the development and testing of an hypothesis. Due to the variety and importance of human mterpretation regarding purposes and methods of information system implementations, the approach by Soft Systems Methodology was adopted as an enabler for an immersion into the problems of a project. As such it was the basis for the abductive stage of the inquiry. The result of this immersion determined the requirements for the choice of further methodologies. The application of the SSM inquiry is guided by seven stages of sets of questions, as the 'technical' aspect of the inquiry framework

Psychopower and Ordinary Madness: Reticulated Dividuals in Cognitive Capitalism

Despite the seemingly neutral vantage of using nature for widely-distributed computational purposes, neither post-biological nor post-humanist teleology simply concludes with the real "end of nature" as entailed in the loss of the specific ontological status embedded in the identifier "natural." As evinced by the ecological crises of the Anthropocene—of which the 2019 Brazil Amazon rainforest fires are only the most recent—our epoch has transfixed the “natural order" and imposed entropic artificial integration, producing living species that become “anoetic,” made to serve as automated exosomatic residues, or digital flecks. I further develop Gilles Deleuze’s description of control societies to upturn Foucauldian biopower, replacing its spacio-temporal bounds with the exographic excesses in psycho-power; culling and further detailing Bernard Stiegler’s framework of transindividuation and hyper-control, I examine how becoming-subject is predictively facilitated within cognitive capitalism and what Alexander Galloway terms “deep digitality.” Despite the loss of material vestiges qua virtualization—which I seek to trace in an historical review of industrialization to postindustrialization—the drive-based and reticulated "internet of things" facilitates a closed loop from within the brain to the outside environment, such that the aperture of thought is mediated and compressed. The human brain, understood through its material constitution, is susceptible to total datafication’s laminated process of “becoming-mnemotechnical,” and, as neuroplasticity is now a valid description for deep-learning and neural nets, we are privy to the rebirth of the once-discounted metaphor of the “cybernetic brain.” Probing algorithmic governmentality while posing noetic dreaming as both technical and pharmacological, I seek to analyze how spirit is blithely confounded with machine-thinking’s gelatinous cognition, as prosthetic organ-adaptation becomes probabilistically molded, networked, and agentially inflected (rather than simply externalized)