Resources
FDA guidance: Blood Establishment Computer System Validation in the User’s Facility — the guidance page for the document this course has quoted from every module, including this one’s III.G interface and legacy-conversion bullets and III.J. Use it to confirm you’re reading the current, final version (CBER, April 2013) and to pull the full PDF if you want more context around any quote in this lesson.
21 CFR 211.68, Cornell Legal Information Institute — the input/output-accuracy paragraph, (b), this module quotes for the first time in this course. Use it to read (a) and (b) together: the requirement to validate the system at all, and the requirement to validate what crosses its edges.
21 CFR 606.165, Cornell Legal Information Institute — distribution and receipt records, applied here to the electronic shipment-data interface to Riverside General Hospital. Use it when you need the exact (b)/(c) field list this module tested the interface against.
21 CFR 11.10, Cornell Legal Information Institute — the full closed-system controls list, including (h), device checks, requoted briefly here after module 5 deferred its depth to this lesson. Use it to see (h) next to (d), (f), and (g), the controls module 5 built out in full.