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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Blood Establishment Computer Systems Validation in the User's Facility |
| Internet: | http://www.fda.gov/cber/gdlns/becsvalid.pdf |
| Origin/Publisher: | Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; |
| Content: | FDA, is issuing this guidance to assist you, 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. |
| Status: | Draft |
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