Software Validation

Introduction

ISO 17025 in chapter 5.4.7.2 states that the commercial off the shelf software (e.g. word processing, database and statistical programs) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/mo­difications should be validated as in 5.4.7.2a).

Software validation process

For the true commercial off the shelf products with no code development for customization, the design specification or code development and code testing are not necessary. The crucial part then is the vendor selection and qualification and the validation process simplifies to just three phases: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).

For more information about EffiValidation 3.0 software validation, go to this section.

Related documents

ISO 17025, chapter 5.4.7.2

GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
 http://www.ispe.org/…/la_id/1.htm

FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002
 http://www.fda.gov/…cm085281.htm

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