Naslov
A Management Approach to Software Validation Requirements

Autori
Hrgarek, Nadica

Vrsta, podvrsta i kategorija rada
Radovi u zbornicima skupova, cjeloviti rad (in extenso), stručni

Izvornik
Proceedings of the 19th Central European Conference on Information and Intelligent Systems / Aurer, Boris ; Bača, Miroslav ; Rabuzin, Kornelije - Varaždin : Fakultet organizacije i informatike Sveučilišta u Zagrebu, 2008, 549-556

ISBN
978-953-6071-043

Skup
19th Central European Conference on Information and Intelligent Systems (CECIIS)

Mjesto i datum
Varaždin, Hrvatska, 24.09.2008. - 26.09.2008

Vrsta sudjelovanja
Predavanje

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
FDA ; medical device ; OTS software ; software validation ; validation

Sažetak
Structured software validation approach varies from organization to organization. All medical device manufacturers shall determine what needs to be validated and how much validation is enough to ensure regulatory requirements are met. The goal of this paper is to describe a management approach to improve the software validation process for medical device manufacturers in order to reduce the validation time and cost. Validation of computerised systems can generate a lot of documentation, be very costly (e.g. validation of an ERP system) for most organizations, but also can provide business and regulatory benefits. The paper discusses the challenges of computer systems validation and highlights some validation methods to help medical device companies to comply with FDA and ISO requirements for the validation of non-product software which includes off-the-shelf (OTS) software.

Izvorni jezik
Engleski

Znanstvena područja
Informacijske i komunikacijske znanosti

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