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A novel audit model for assessing quality in non-regulated researchEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The need for Quality standards in non-regulated research is a matter of considerable current debate. Whilst a number of such guidelines have been developed over recent years, their successful implementation remains a challenge to all. In order to assess whether research standards are indeed improving on the bench following the instigation of such a quality system, a question posed by both senior management and scientists alike, an independent compliance programme is required. However, given the lack of predicate rules, naivety to audit process and general sensitivity to external scrutiny within the scientific ranks, then w...
Source: The Quality Assurance Journal - May 15, 2009 Category: Health Management Authors: S. G. Volsen, M. M. Masson Source Type: journals

Abstracts of the Society of Quality Assurance 25th Annual MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract
Source: The Quality Assurance Journal - April 1, 2009 Category: Health Management Tags: Abstracts Source Type: journals

Abstracts of the Society of Quality Assurance 24th Annual MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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Source: The Quality Assurance Journal - April 1, 2008 Category: Health Management Tags: Abstracts Source Type: journals

Abstracts of the Society of Quality Assurance 23rd Annual MeetingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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Source: The Quality Assurance Journal - April 1, 2007 Category: Health Management Source Type: journals

Does the MAD system make test facilities mad?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
There needs more clarity in ad hoc Good Laboratory Practice (GLP) certification conferred to test facilities of non-member economies. There is a similar kind of issue with the 'GLP status' of the test data generated by a test facility that has been conferred GLP certification by the country that is only a provisional adherent. In both cases, the objective of the Mutual Acceptance of Data (MAD) system will not be fulfilled if the answer is 'no'. Copyright © 2006 John Wiley & Sons, Ltd.
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: V. Amalan Stanley Source Type: journals

Integrating maintenance activities and Quality Assurance in a research and development (R&D) systemEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A well-balanced maintenance program furnishes information and instructions to personnel involved in maintaining existing equipment, provides current information on the availability and location of maintenance materials, improves utilization of labor forces and increases equipment reliability. Planned and preventive maintenance procedures where components are serviced and changed when they approach the end of their useful lives can be augmented by suitable means, which continuously check vital machine functions. Quality Assurance can be seen as a management system that brings maintenance activities undertaken by all parties...
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Debasish Basak Source Type: journals

Strengthening GLP compliance through internal auditsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Quality Assurance (QA) strategy for assessing Good Laboratory Practice (GLP) compliance at different testing facilities varies from focusing on study data verification to taking a quality system approach. As a best practice and to ensure overall compliance with GLP regulations, the Quality Assurance Unit (QAU) should perform three types of internal audits: study-specific, process-based, and system inspection. These internal audits serve as a tool to ascertain whether a GLP compliance program is functioning correctly. Information gathered from these audits can also be used to provide assistance during the evolution of a...
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Henry Li, Dominique Pifat, Gerald Klein, Steve Petteway Source Type: journals

The process for implementation of a Quality Management System within a multi-functional cereal laboratoryEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The intent of this study was to design, document and implement a Quality Management System (QMS) into a laboratory that incorporated both research and development (R&D) and routine analytical activities. In addition, it was necessary for the QMS to be easily and efficiently maintained to: (a) provide documented evidence that would validate the system's compliance with a certifiable standard, (b) fit the purpose of the laboratory, (c) accommodate prevailing government policies and standards, and (d) promote positive outcomes for the laboratory through documentation and verification of the procedures and methodologies implem...
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Roslyn Ferguson, Robert Henry, Andy Inkerman Source Type: journals

Moral decision-making among professionals in the pharmaceutical industry: a 'communities of practice' modelEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Ethical decision-making in a major USA pharmaceutical company was studied. One prevailing model for investigating professional ethics has been to assume that the professional domain itself is morally neutral, and that individuals simply deploy their own personal, privately held values within their professions. Our research, however, indicates that the professional context - which we describe by means of the current concept 'communities of practice' - plays a significant role in guiding how these researchers and project managers express their beliefs about what is appropriate behavior in their own profession. We further dis...
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Thomas D. Pearson, James W. Aldridge, Mark Winkel Source Type: journals

GLP SOPs for equipment calibration and maintenance part 3: process mapping for SOP developmentEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Ask almost anyone who has been involved in writing Standard Operating Procedures (SOPs) about how they learned to do it and chances are the answer will be that they just sat down and wrote their ideas, maybe using a standard format. Although process flows and flow charts have been an integral part of the computer world for as long as most care to remember, it has only been in the past decade or so that the concepts of process design and process flows have started to enter the realm of SOP development in the pharmaceutical industry. In this installment of the series, we will describe one process design approach to developin...
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Irina Colligon, Michelle Rosa Source Type: journals

Validating pharmaceutical systems: good computer practice in life science manufacturing, edited by John Andrews, CRC Press/Sue Horwood Publishing Ltd., West Sussex, England, UK, 3 August 2005, 576 p., USD 249.95, ISBN 0-8493-2324-XEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: R.D. McDowall Source Type: journals

European Qualified Person AssociationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Wolfgang Heimes, on behalf of European Qualified Person Association Source Type: journals

What's New?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The What's New? section in the Quality Assurance Journal aims to draw attention to items of importance to QA professionals. There is usually a three-month interval between final submission of manuscripts and distribution of the journal. For this issue, the entries in the What's New? section arise from the period of 1 June 2006 to 31 August 2006. If you feel that there is any other new information that should be brought to the attention of readers, please let us know by e-mailing . Copyright © 2006 John Wiley & Sons, Ltd.
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Rita Hattemer-Apostel Source Type: journals

Calendar of eventsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract
Source: The Quality Assurance Journal - January 16, 2007 Category: Health Management Authors: Katy Sotirov Source Type: journals

Does Quality Assurance need Quality Assurance?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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Source: The Quality Assurance Journal - December 1, 2006 Category: Health Management Authors: Rita Hattemer-Apostel Source Type: journals

The role of the monitor in veterinary clinical studiesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This paper covers the current best practice for the clinical study monitor. It describes and qualifies these activities as outlined in the International Conference on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH) Good Clinical Practice (GCP) guidelines (GL9). Copyright © 2006 John Wiley & Sons, Ltd.
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Iain McPhee, Monte Reimers Source Type: journals

The role of the study director in GLPEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
With the complexity of today's studies, it has become increasingly critical that Study Directors understand all disciplines involved in studies under their responsibility. Every phase of a study directly impacts the outcome. If the Study Director does not have sufficient expertise to evaluate problems and issues in all areas as they occur, then study integrity is compromised. The physical location of the Study Director in a multi-site study is of less importance than the education, experience and expertise of that individual. The Study Director must be the single point of control and truly qualified to evaluate all the pha...
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Deborah Eyer Garvin Source Type: journals

Process improvement evaluation approach using flow diagramsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Maintaining company processes will afford optimum operation and enhance the company's quality management system. A vital part of maintaining processes is their periodic evaluation. An important part of the monitoring and evaluation process is the flow diagram. A detailed flow diagram is an important tool that affords ease in visualizing the total process and is an aid in locating problem areas. The evaluation of a process is broken down into 15 steps. These steps cover gathering pertinent information, such as problem symptoms from knowledgeable sources and carrying these through their route to potential problem areas to th...
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Paul C. Constant Jr. Source Type: journals

GLP SOPs for equipment calibration and maintenance. Part 2: an organized approach to streamlining procedural documentationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This article proposes an alternative and more efficient approach to building a manageable set of procedural/instructional documents that will help an organization meet its scientific and regulatory needs while alleviating the strain that a gargantuan SOP system can put on its personnel.Among the benefits of this approach are: (1) Documents are organized to follow the logical and chronological flow of the activities they describe. (2) Documents can be located quickly. (3) Users will find what they need to know, presented in a concise manner, without superfluous information. (4) Increased usability of the documents since the...
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Michelle Rosa, Irina Colligon Source Type: journals

A practical guide to quality management in clinical trial research. G.D. Ogg, CRC Taylor & Francis, Boca Raton, FL, USA, 2006, 214 p., USD 169.96, ISBN 0-8493-9722-7Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Nigel Dent Source Type: journals

Improving service quality in the global economy: achieving high performance in public and private sectors, 2nd edition. Michael E. Milakovich, Auerbach Publications, 432 p., GBP 39.99 or USD 69.99, ISBN 0-8493-3819-0Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: David Long Source Type: journals

Writing and reviewing skills. Martin Robinson, 2005 by ICR Publishing, Marlow, Bucks, UK, 46 p., ISBN 1-905238-00-2, GBP 15.00 (UK), EUR 30.00 (Europe), USD 35.00 (Rest of the World)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Bob McDowall Source Type: journals

What's New?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The What's New? section in the Quality Assurance Journal aims to draw attention to items of importance to QA professionals. There is usually a three-month interval between final submission of manuscripts and distribution of the journal. For this issue, the entries in the What's New? section arise from the period of 1 March 2006 to 31 May 2006. If you feel that there is any other new information that should be brought to the attention of readers, please let us know by e-mailing . Copyright © 2006 John Wiley & Sons, Ltd.
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Rita Hattemer-Apostel Source Type: journals

Calendar of EventsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
No Abstract
Source: The Quality Assurance Journal - October 11, 2006 Category: Health Management Authors: Rita Hattemer-Apostel Source Type: journals

EditorialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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Source: The Quality Assurance Journal - September 1, 2006 Category: Health Management Authors: Anthony B. Jones Source Type: journals

Abstracts of the 22nd Society of Quality Assurance Annual Meeting Presentation AbstractsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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Source: The Quality Assurance Journal - April 1, 2006 Category: Health Management Source Type: journals