Many theoretical and practical problems arise at different stages of the design/manufacturing process during development of a pump. The experience obtained in pump development proves that the quality of a pump depends on many factors, which should he satisfied to receive good results. At the same time, the theory of engineering design principles exists, which is applicable to designing various ...

the purpose of this article is to discuss the allocation issues in managerial accounting. the allocation problem has several dimensions, some of which are subtle. in fact ,almost all of our revenue recognition and matching efforts require allocation. that is, deciding to what periods they (revenues and expenses) should be assigned, in conclusion, practitioners have honestly believed that alloca...

A striking characteristic of Japanese factories is the extent of process control: from both the technical and the social viewpoint the labour and production system is controlled down to the very last detail. The characteristics of management and organization which underlie this are closely interwoven with Japanese culture. This explains why the work content. working conditions and working relat...

'If it's not written down, then it didn't happen!' The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is...

BACKGROUND The EU Clinical Trials Directive (EUCTD) and the EU Clinical Trials Regulation aim to harmonize good clinical practice (GCP) of clinical trials across Member States. Using the Netherlands as a case study, this paper analyzes how endeavours to implement the EUCTD set in motion a dynamic process of institutional change and institutional work. This process lead to substantial difference...

Aim: Ensuring correct and complete source data in clinical trials is of outmost importance. Journal audits in the Dept. of Oncology revealed that source data were not always complete and thus the need to identify specific areas and extent of deficiencies. Methods: Coupling of data from patient's clinical records and electronic medicine ordering records with findings by research nurse at point o...

AIM The aim of this study was to evaluate the process of accreditation resulting in improvement of the Institutional Review Board (IRB) functioning. METHODOLOGY Randomly selected projects from years 2007 (before accreditation), 2010 (after accreditation), and 2013 (after reaccreditation) were evaluated to assess parameters, namely, submission of good clinical practices (GCPs), completeness of...