Search Our Scientific Publications & Authors

Qual Assur 2005 Apr-Jun;11(2):85-102

Saint Louis University, St. Louis, Missouri.

The continued rapid worldwide diffusion of clinical hyperbaric facilities has substantially increased interest in clinical quality assessment and service improvement. This paper examines major issues, perspectives, and methods integral to the measurement and improvement of the quality of care provided to hyperbaric patients and their relevance and applicability across different societies. Special focus is directed toward the importance of quality assessment and improvement of clinical hyperbaric care, multiple stakeholder perspectives on improved clinical quality, measurement of clinical outcomes of hyperbaric care, importance of facility accreditation, process improvement methods, and the future importance of quality management in clinical hyperbaric facilities. Read More

Qual Assur 2003 Apr-Jun;10(2):91-106

Merck Research Laboratories, West Point, Pennsylvania 19486, USA.

Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. Read More

Qual Assur 2001 Jul-Dec;9(3-4):217-24

USACE Washington Aqueduct, 5900 MacArthur Blvd. NW, Washington, DC 20016, USA.

The task of managing laboratory data is not a new one. Over the past two decades, the use of Laboratory Information Management Systems (LIMS) has revolutionized how laboratories manage their data. A LIMS is more than software; it has become the workhorse of the laboratory, encompassing laboratory work-flow combined with user input, data collection, instrument integration, data analysis, user notification, and delivery of information and reporting. Read More

Qual Assur 2001 Jan-2002 Mar;9(1):31-41

United States Environmental Protection Agency (US EPA), Office of Enforcement and Compliance Assurance (OECA), National Enforcement Investigations Center (NEIC), Denver Federal Center, Denver, Colorado 80225-0027, USA.

The US Environmental Protection Agency-National Enforcement Investigations Center (NEIC) of Denver, Colorado is the specialty technical arm of the Office of Enforcement and Compliance Assurance (OECA) within the US EPA. NEIC is a center for technical support nationwide to state, local, tribal, and federal environmental enforcement and compliance assurance programs. NEIC is a source of expertise for technical analysis, compliance monitoring, engineering evaluations, forensic laboratory activities, information management, computer forensics, and witness testimony. Read More

Qual Assur 1999 Oct-Dec;7(4):207-16

Divisional Quality Assurance Officer, Division of Laboratories, Illinois Environmental Protection Agency, 1021 North Grand Avenue East, Springfield, Illinois, USA.

To implement an effective and efficient quality system in a network of established environmental testing laboratories requires a committed long-term effort that is potentially fraught with multiple obstacles. This presentation discusses one state's ongoing efforts at implementing such a system. First is the need to convince management of the rationale for a quality systems-based approach versus the traditional QA/QC program. Read More

Qual Assur 1998 Jul-Sep;6(3):165-72

Country Consultancy Ltd, Milton Malsor, England, United Kingdom.

Quality Assurance (QA) has played a pivotal role within Good Laboratory Practice (GLP) since its inception in 1976. GLP is now recognized as a quality standard, as can be seen from the introductory statement of the recently issued OECD Principles of GLP (revised in 1997) that clearly state "GLP is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported". We can, therefore, see a close comparison between GLP compliance and the ISO/EN accreditation systems that have been adopted by other institutes on a worldwide basis. Read More

Qual Assur 1998 Jul-Sep;6(3):137-48

Istituto di Ricerche Biomediche A. Marxer, RBM, Torino, Italy.

The market, and therefore the inevitable need to produce and sell products and services, encourages companies to try to ensure that they themselves and their products can be recognized and characterized. It thus follows that the producer's activities must be qualified with special certificates. Over the last few years the number of companies wishing to qualify their organization and their products has increased considerably. Read More

Qual Assur 1995 Dec;4(4):283-7

Bentley & Associates, Middleboro, MA 02346, USA.

Environmental monitoring and Good Laboratory Practice programs are similar when looked at empirically. Both address quality issues, human or environmental safety, and have set procedures to assure the concomitant results. However, when compared at the operational level, they can be best described as very different. Read More

Qual Assur 1995 Dec;4(4):274-82

Compliance Assurance, Springborn Laboratories, Inc., Wareham, MA 02571, USA.

Accreditation or certification is a recognition given to an operation or product that has been evaluated against a standard; be it regulatory or voluntary. The purpose of accreditation is to provide the consumer with a level of confidence in the quality of operation (process) and the product of an organization. Environmental Protection Agency/OCM has proposed the development of an accreditation program under National Environmental Laboratory Accreditation Program for Good Laboratory Practice (GLP) laboratories as a supplement to the current program. Read More

Qual Assur 1995 Mar;4(1):41-59

Southwest Research Institute, San Antonio, Texas 78228-0510, USA.

Qual Assur 1995 Mar;4(1):20-8

United States Environmental Protection Agency (2225A), Agriculture and Ecosystems Division, Washington, DC 20460, USA.

The reorganization and consolidation of the United States Environmental Protection Agency's (EPA's) Headquarters Enforcement and Compliance programs into a new Office of Enforcement and Compliance Assurance (OECA) is now complete. The Good Laboratory Practice (GLP) inspection program is now part of the Office of Compliance, one of the principal offices in this new organization. The role of the Office of Compliance and the implications of these changes for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) GLP programs are addressed. Read More

Qual Assur 1994 Sep;3(3):312-5

Springborn Laboratories, Inc., Environmental Sciences Division, Wareham, Massachusetts 02571.

Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Read More

Qual Assur 1994 Sep;3(3):242-7

U.S. EPA, National Enforcement Investigations Center, Denver, Colorado 80225.

An investigation of alleged data fraud at a pesticide analytical laboratory led EPA to take a closer look at the Good Laboratory Practice (GLP) inspection program. There was special focus on changes which might be made in the program to enhance the chances of detecting fraud in regulated studies. To this end, the Assistant Administrator of the Office of Prevention, Pesticides and Toxic Substances (OPPTS) requested EPA's Office of Inspector General (OIG) to examine the GLP program. Read More

Qual Assur 1994 Sep;3(3):222-36

U.S. Environmental Protection Agency, Washington, DC 20460.

Regulatory and program developments during the past year are reviewed. These include the Good Laboratory Practices (GLP) enforcement case initiative, the implications of the Bio-Tek Industries decision, and the status of the Craven Laboratories case. The status of the Agency's laboratory accreditation workgroup is discussed, as well as the responses to date to the Inspector General's reports on EPA's GLP program. Read More

Qual Assur 1993 Dec;2(4):332-8

National Water Research Institute, Environment Canada, Burlington, Ontario.

Principles of good laboratory practice (GLP) and laboratory accreditation programs, particularly as they pertain to the environmental sector, are reviewed. The multitude of programs is proving costly for many laboratories and there is mounting pressure to develop reciprocity agreements between programs and to consolidate nationally and internationally. Inclusion of GLP and laboratory accreditation requirements in government regulations is resulting in a significantly increased number of laboratories participating in these programs. Read More