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Zdrowie i gospodarka · 29.10.2007

Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility" dated October 2007. The draft guidance document provides assistance to blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. In the Federal Register of March 9, 2005 (70 FR 11679), FDA withdrew the guidance document entitled "Draft Guideline for the Validation of Blood Establishment Computer Systems," issued on September 28, 1993, and is issuing this guidance to reflect our current considerations on this topic.

Source: Federal Register — Food and Drug AdministrationOpen original release →