ISBT Blood Bank Automation Validation Guidelines

The International Society for Blood Transufion issued “Guidelines for Validation and Maintaining the Validation State of Automated Systems in Blood Banking” dated December 2002. This document provides guidance on Blood Establishment responsibilities and approach to validation or automated systems including Blood Establishment Computer Systems (BECS). The document is at the link provided.

This information although directed at Blood Establishments may be useful reference for BECS manufacturers as well.

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Agile Methods for Medical Device and Health IT Software

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