Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility that 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. This replaces the 9/93 document, Draft Guideline for the Validation of Blood Establishment Computer Systems. To download this guidance, click here. To view this notice, click here.