federal_register: 2013-06865

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2013-06865 Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility" dated April 2013. The 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. The guidance announced in this document finalizes the draft guidance of the same title dated October 2007. 2013-03-26 2013 3 https://www.federalregister.gov/documents/2013/03/26/2013-06865/guidance-for-industry-blood-establishment-computer-system-validation-in-the-users-facility https://www.govinfo.gov/content/pkg/FR-2013-03-26/pdf/2013-06865.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility" dated April 2013. The guidance document provides assistance to...

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