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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.