Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility.

摘要

We, FDA, are 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. This guidance addresses a blood establishments validation of its Blood Establishment Computer System (system) which incorporates Blood Establishment Computer Software (BECS). In the context of this guidance, the term user's facility means the blood establishment.