( )Engineering Information Abstracts Part II 161

Keywords: Software engineering; Industrial applications; Man-agement; Product design; Marketing

Title: RESPONSIBILITIES, RESOURCES AND RESULTS:PRACTICALITIES OF TESTING IN-HOUSE DEVELOPEDCLINICAL SOFTWARE

( )Author s : Roberts, ClareCorporate Source: Amgen Ltd, Cambridge, UKConference Title: Proceedings of the 1997 IEE Colloquium onResponsibilities and Practicalities for Testing PharmaceuticalSoftware Conference Location: London, UK Conference Date:19970318

Ž .Source: IEE Colloquium Digest n 173 Mar 18 1997. IEE,Stevenage, Engl. p 5r1-5r3 CODEN: DCILDN ISSN: 0963-3308Publication Year: 1997Abstract: The testing of computer software used in the phar-maceutical industry is important in ensuring that the softwareperforms in the manner that it was designed to do. Thereliability of data processed by computer systems is a majorconcern both for regulatory authorities and pharmaceuticalcompanies which use it to determine the safety and efficacy ofpharmaceutical products. In this regard, the regulatory andbusiness responsibilities of the pharmaceutical industry as wellas the various resources needed in testing clinical software arediscussed. 2 Refs. In English EI Order Number:EIP98024076091Keywords: Computer software selection and evaluation; Medi-cal applications; Drug products plants; Software engineering;Quality control; Laws and legislation

Title: CAN YOU VALIDATE ENTERPRISE SYSTEMS SUCHAS SAP Rrrrrr3?

( )Author s : Deacon, Julia; Evans, PeterCorporate Source: Deloitte and Touch Consulting Group -Praxis, Bath, UKConference Title: Proceedings of the 1997 IEE Colloquium onResponsibilities and Practicalities for Testing PharmaceuticalSoftware Conference Location: London, UK Conference Date:19970318

Ž .Source: IEE Colloquium Digest n 173 Mar 18 1997. IEE,Stevenage, Engl. p 4r1-4r3 CODEN: DCILDN ISSN: 0963-3308Publication Year: 1997Abstract: It is important to validate enterprise systems thatare used in the pharmaceutical industry such as the SAP Rr3.One of the many benefits of enterprise system validation isthat it ensures compliance with regulatory requirementsconcerning product quality. In addition, a well validated enter-prise system will be robust in operation and provide control ofdata and information, while addressing the issue of datasecurity. While the validation of enterprise systems is possible,it should not be based on testing alone but on a rigorousapproach that seeks to improve control at all stages of theproject. 1 Refs. In English EI Order Number: EIP98024076090Keywords: Process control; Drug products plants; Computersoftware selection and evaluation; Quality control; Cost effec-tiveness

Title: RESPONSIBILITIES AND PRACTICALITIES FORTESTING PHARMACEUTICAL SOFTWARE - BRIDGINGTHE GAP

( )Author s : Wingate, G.A.S.Corporate Source: Eutech Engineering, Cleveland, OH, USAConference Title: Proceedings of the 1997 IEE Colloquium onResponsibilities and Practicalities for Testing PharmaceuticalSoftware Conference Location: London, UK Conference Date:19970318

Ž .Source: IEE Colloquium Digest n 173 Mar 18 1997. IEE,Stevenage, Engl. p 1r1-1r4 CODEN: DCILDN ISSN: 0963-3308Publication Year: 1997Abstract: Many pharmaceutical manufacturers have realizedthe benefits of forming partnerships with their software sys-tems suppliers to address the stringent validation require-

Ž .ments under the Good Manufacturing Practice GMP regula-tions. Both manufacturers and suppliers are beginning tounderstand the need to share in the responsibility of creatingsoftware with built-in quality rather than relying on tests toconfirm what should already be inherent. In English EI OrderNumber: EIP98024076088Keywords: Computer software selection and evaluation; Medi-cal applications; Drug products plants; Software engineering;Quality control

Title: IMPACT OF AN ISO 9001 COMPLIANT QUALITYMANAGEMENT SYSTEM ON A UNIVERSITY RESEARCHENTERPRISE

( )Author s : Walker, A.J.Corporate Source: Univ of the Witwatersrand, Johannesburg,S AfrSource: TQM Magazine v 9 n 6 1997. p 397-402 CODEN:TQMMEF ISSN: 0954-478XPublication Year: 1997Abstract: The Software Engineering Applications LaboratoryŽ .SEAL is a university-based research enterprise with projectactivity in the areas of software quality management and thedevelopment of specialized engineering applications. TheSEAL was awarded a third party ISO 9001 certification forsoftware development in July 1995. Reviews the motivation fordeveloping an ISO 9001 compliant quality management sys-

Ž .tem QMS . Examines some of the special challenges whichhad to be faced while developing the QMS. Considers benefits

Ž .which have accrued from this experience. Author abstract 2Refs. In English EI Order Number: EIP98024074991Keywords: Total quality management; Computer software;Standards; Industrial research; Engineering research

Title: SOFTWARE IN SCIENTIFIC INSTRUMENTS - AGOOD PRACTICE GUIDE

( )Author s : Wichmann, B.A.Corporate Source: CMOT, Middlesex, UKConference Title: Proceedings of the 1997 IEE Colloquium onResponsibilities and Practicalities for Testing Pharmaceutical