laboratory software validation: can you prove it works?

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There is now scarcely a procedure in the chemical laboratory which does not involve the use of com- puters at some stage. Concerns have built up over many years around possible errors and omissions in the process which eventually puts chemicals in the hands of the public. For many years industries which produce products for sensitive markets, notably the pharmaceutical and agrochemical industries, have accepted that their activities should be closely moni- tored and controlled. At the same time, many compa- nies have accepted that it is in their own interest to demonstrate to their customers that their procedures are carefully developed and scrupulously controlled. In this atmosphere several schemes, such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Automated Laboratory Prac- tice (GALP) and IS0 Guide 25 compete to provide the right regulatory framework. Laboratory automation and information management ELSEVIER Laboratory Automation and Information Management 31 (1995) vii Preface Laboratory Software Validation: Can You Prove It Works? A one-day meeting was organised by the Com- puter Applications and Chemometrics Groups of the Royal Society of Chemistry and held at the Univer- sity of Wolverhampton on 13th February 1995. The aims of the meeting were to describe what these schemes are and how they work from the perspective of personal experience. Five of the papers presented at this meeting are published in this issue of the Journal. M.J. Adams School of Applied Sciences University of Wolverhampton Wulfruna Street Wolverhampton WV1 ISB, UK Elsevier Science B.V. SSDI 0925-5281(95)00019-4

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There is now scarcely a procedure in the chemical laboratory which does not involve the use of com- puters at some stage. Concerns have built up over many years around possible errors and omissions in the process which eventually puts chemicals in the hands of the public. For many years industries which produce products for sensitive markets, notably the pharmaceutical and agrochemical industries, have accepted that their activities should be closely moni- tored and controlled. At the same time, many compa- nies have accepted that it is in their own interest to demonstrate to their customers that their procedures are carefully developed and scrupulously controlled. In this atmosphere several schemes, such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Automated Laboratory Prac- tice (GALP) and IS0 Guide 25 compete to provide the right regulatory framework.

Laboratory automation and information management

ELSEVIER Laboratory Automation and Information Management 31 (1995) vii

Preface

Laboratory Software Validation: Can You Prove It Works?

A one-day meeting was organised by the Com- puter Applications and Chemometrics Groups of the Royal Society of Chemistry and held at the Univer- sity of Wolverhampton on 13th February 1995. The aims of the meeting were to describe what these schemes are and how they work from the perspective of personal experience. Five of the papers presented at this meeting are published in this issue of the Journal.

M.J. Adams School of Applied Sciences

University of Wolverhampton Wulfruna Street

Wolverhampton WV1 ISB, UK

Elsevier Science B.V. SSDI 0925-5281(95)00019-4